China's 2019 Drug Review Report Released: 8,082 Applications Received, Including 130 NDAs
VCBeat has learned that on July 30, 2020, the National Medical Products Administration released the “2019 Annual Drug Evaluation Report.” The full text of the report is as follows:
2019 was a milestone year in the history of pharmaceutical regulatory legislation. The newly enacted Vaccine Administration Law is the world’s first comprehensive law on vaccine management, while the newly revised Drug Administration Law represents the first comprehensive revision in nearly two decades. These two laws codify into legal form the strategic directives of the Central Committee of the Communist Party of China and the State Council, public expectations, and the experience gained from reforms of the review and approval system, thereby providing robust legal safeguards for consolidating and advancing reforms in drug review and approval. In that year, under the strong leadership of the National Medical Products Administration (NMPA), the Center for Drug Evaluation (CDE) of the NMPA diligently studied and implemented the Drug Administration Law and the Vaccine Administration Law, continuously promoted reforms in the drug review and approval system, and actively established a science-based management system for drug evaluation oriented toward processes. Adhering to principles of compliance with laws and regulations, openness and transparency, service orientation, and scientific standardization in review practices, the CDE effectively ensured the safety, efficacy, and accessibility of drugs, thereby safeguarding the health rights and interests of the public.
In 2019, the Center for Drug Evaluation (CDE) accepted 8,082 new registration applications (including 5 combination products involving devices; counted by acceptance number, unless otherwise specified). Among these, 6,199 applications required technical review (including 4,907 applications subject to both technical review and administrative approval by the CDE), while 1,878 applications underwent direct administrative approval (without technical review, as defined above).
Among the 8,077 drug registration applications accepted by the Center for Drug Evaluation (CDE), 6,475 were for chemical drugs, accounting for 80.2% of the total number of registration applications accepted in 2019. For details on the acceptance of various types of drug registration applications from 2016 to 2019, see Figure 1.
Figure 1. Acceptance of Various Drug Registration Applications, 2016–2019
Note: 1. The number of applications accepted in 2019 included five registration applications for combination device products; therefore, the total number of registration applications accepted in 2019 shown in the above figure exceeds the sum of those accepted for traditional Chinese medicines, chemical drugs, and biological products. 2. As the Center for Drug Evaluation (CDE) commenced its direct administrative approval operations in 2017, there were no registration applications subject to direct administrative approval in 2016; all accepted registration applications required technical review.
Figure 2. Acceptance of Various Drug Registration Applications Requiring Technical Review, 2017–2019
In 2019, a total of 6,199 registration applications requiring technical review were accepted, representing an 11.21% increase compared with 2018. Among these, there were 4,937 applications for chemical drugs, up by 10.72% from 2018 and accounting for 79.64% of all accepted registration applications requiring technical review; there were 257 applications for traditional Chinese medicines (TCM), down by 14.33% from 2018; and there were 1,005 applications for biological products, up by 23.3% from 2018. For details on the acceptance of registration applications requiring technical review for chemical drugs, TCM, and biological products from 2016 to 2019, see Figure 2.
The Center for Drug Evaluation (CDE) accepted a total of 700 registration applications for Class 1 innovative drugs (covering 319 drug varieties). (For chemical drugs, the number of varieties is calculated based on active ingredients; for traditional Chinese medicines and biological products, the number of varieties is calculated based on generic drug names; the same applies below.) The number of varieties increased by 20.8% compared with 2018. Among these, IND applications for Class 1 innovative drugs were accepted for 302 varieties, representing a 26.4% increase from 2018; NDA applications for Class 1 innovative drugs were accepted for 17 varieties, a decrease of 8 varieties compared with 2018.
The Center for Drug Evaluation (CDE) accepted 528 registration applications for domestically produced Class 1 innovative drugs (covering 244 varieties), including 503 clinical trial applications (228 varieties) and 25 marketing authorization applications (16 varieties). By drug type, there were 401 applications for chemical drugs (144 varieties) and 127 for biological products (100 varieties). The indications for these innovative drugs were primarily concentrated in the fields of oncology, anti-infectives, and digestive system diseases.
The Center for Drug Evaluation (CDE) accepted 157 registration applications for imported originator chemical drugs under Category 5.1, covering 92 drug varieties, and 172 registration applications for imported innovative drugs under Category 1, covering 75 drug varieties. The indications of these innovative drugs were primarily concentrated in the fields of oncology, endocrinology, and neurological disorders.
1. Acceptance Status of Chemical Drug Registration Applications
The Center for Drug Evaluation (CDE) accepted 6,475 registration applications for chemical drugs. Among these, 694 were Investigational New Drug (IND) applications, representing a 51.9% increase compared to 2018; 130 were New Drug Applications (NDA), representing a 21.5% increase compared to 2018; 1,047 were Abbreviated New Drug Applications (ANDA) for generic drugs, representing a 6.6% increase compared to 2018; and 1,038 were supplemental applications for consistency evaluation (covering 308 varieties), with the number of applications increasing by 71% compared to 2018. For details on the acceptance of various types of chemical drug registration applications in 2019, see Figure 3. For details on the acceptance of registration applications for chemical drugs, including INDs, NDAs, and consistency evaluations, from 2016 to 2019, see Figure 4.
Figure 3. Acceptance of Various Registration Applications for Chemical Drugs in 2019
Figure 4. Acceptance of Registration Applications for Chemical Drugs, Including INDs, NDAs, and Consistency Evaluations, 2016–2019
Note: The Center for Drug Evaluation has been responsible for the quality and efficacy consistency evaluation of generic drugs since August 2017.
(1) IND Applications and NDA Acceptance Status for Domestically Produced and Imported Chemical Drugs
Figure 5. Distribution of Therapeutic Areas for Domestically Produced and Imported Chemical Drug IND and NDA Applications Accepted in 2019
In chemical drug IND applications, 444 IND applications for domestically produced chemical drugs and 250 IND applications for imported drugs were accepted. The indications for domestically produced chemical drug IND applications were mainly concentrated in the fields of anti-tumor, digestive system, and anti-infective drugs, while those for imported IND applications were mainly concentrated in the fields of anti-tumor, anti-infective drugs, and nervous system disorders.
For chemical drug New Drug Applications (NDAs), 45 NDAs for domestically produced chemical drugs and 85 NDAs for imported chemical drugs were accepted. The indications for domestically produced chemical drug NDAs were primarily concentrated in the fields of antineoplastic and anti-infective agents, while those for imported chemical drug NDAs were mainly focused on oncology and the nervous system. For details on the distribution of therapeutic areas for Investigational New Drug (IND) applications and NDAs for both domestically produced and imported chemical drugs accepted in 2019, see Figure 5.
(2) Acceptance Status of Class 1 Innovative Chemical Drugs
The Center for Drug Evaluation (CDE) accepted 573 registration applications for Class 1 innovative chemical drugs (covering 219 varieties), representing a 39.5% increase in the number of varieties compared to 2018. Among these, Investigational New Drug (IND) applications were accepted for 206 varieties, a 46.1% increase from 2018; while New Drug Applications (NDA) were accepted for 13 varieties, a decrease of 3 compared to 2018.
Figure 6. Acceptance of Registration Applications for Innovative Chemical Drugs, 2016–2019
Among the 219 Class I innovative chemical drug registration applications, 144 were for domestically produced innovative chemical drugs, and 75 were for imported innovative chemical drugs. For details on the acceptance of innovative drug registration applications from 2016 to 2019, see Figure 6.
2. Acceptance of Traditional Chinese Medicine Registration Applications
The Center for Drug Evaluation accepted 423 traditional Chinese medicine (TCM) registration applications, including 17 Investigational New Drug (IND) applications, 3 New Drug Applications (NDA), and 3 Abbreviated New Drug Applications (ANDA). For details on the acceptance of various TCM registration applications in 2019, see Figure 7. For details on the acceptance of TCM IND, NDA, and ANDA applications from 2016 to 2019, see Figure 8.
Figure 7. Acceptance of Various Registration Applications for Traditional Chinese Medicine in 2019
Figure 8. Acceptance of IND Applications, NDAs, and ANDAs for Traditional Chinese Medicine Products, 2016–2019
(1) Status of IND Application Acceptance for Traditional Chinese Medicine
Among the 17 Investigational New Drug (IND) applications for traditional Chinese medicines (Categories 5, 6, and 8), the indications were primarily concentrated in the therapeutic areas of gastroenterology, respiratory diseases, and orthopedics, accounting for 76% of all IND applications for traditional Chinese medicines.
(2) Acceptance Status of New Traditional Chinese Medicine Drugs
The Center for Drug Evaluation accepted 18 registration applications for new traditional Chinese medicine (TCM) drugs of Categories 5–6 (covering 18 varieties, with no registration applications for TCM drugs of Categories 1–4), including 15 investigational new drug (IND) applications (15 varieties) and 3 new drug applications (NDA) (3 varieties), representing a decrease from 2018 levels.
3. Acceptance of Registration Applications for Biological Products
Figure 9. Acceptance of Various Registration Applications for Biological Products in 2019
The Center for Drug Evaluation (CDE) accepted 1,179 registration applications for biological products. Among these, 310 were Investigational New Drug (IND) applications (7 for preventive use and 303 for therapeutic use), representing a 4% increase compared to 2018. Additionally, 124 New Drug Applications (NDA) for biological products were accepted (7 for preventive use and 117 for therapeutic use), marking a 45.9% increase compared to 2018. For detailed information on the acceptance of various types of registration applications for biological products in 2019, see Figure 9. For details on the acceptance of IND and NDA applications for biological products from 2016 to 2019, see Figure 10.
Figure 10. IND Applications and NDA Acceptances for Biological Products, 2016–2019
(1) Acceptance Status of Class I Innovative Biologic Drugs
The Center for Drug Evaluation accepted 127 registration applications for innovative Class I biological products (covering 100 varieties), representing a 3.3% increase in the number of applications compared to 2018. Among these, there were 2 applications for preventive biological products and 125 for therapeutic biological products. Of the registration applications for innovative Class I biological products, 121 were Investigational New Drug (IND) applications (covering 96 varieties), an 8% increase from 2018; and 6 were New Drug Applications (NDAs) (covering 4 varieties, all therapeutic biological products), a decrease of 5 applications compared to 2018.
Figure 11 Distribution of Therapeutic Areas for Class 1 Therapeutic Biologic IND Applications Accepted in 2019
The Center for Drug Evaluation accepted 119 Investigational New Drug (IND) applications for Class 1 therapeutic biological products (covering 95 distinct agents). The indications were primarily concentrated in the field of anti-tumor therapy, accounting for 69% of all IND applications for Class 1 therapeutic biological products. See Figure 11 for the detailed distribution by therapeutic area.
1. Annual Review and Approval Completion Status
From 2015 to 2018, the Center for Drug Evaluation (CDE) expanded its review capacity through multiple channels—including broadening review pathways, strengthening project management, large-scale recruitment, and seconding personnel from provincial administrations—thereby significantly improving review efficiency. These measures essentially resolved the backlog of drug registration applications. Consequently, the CDE’s focus gradually shifted from clearing the backlog to enhancing the on-time review and approval rate for drug registration applications. In 2019, the CDE achieved an on-time review and approval rate exceeding 90% for all categories of registration applications, including traditional Chinese medicines, chemical drugs, and biological products. This basically fulfilled the work target set by the State Council’s “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” (Guo Fa [2015] No. 44, hereinafter referred to as “Document No. 44”), which aimed to achieve approvals within the prescribed timeframes by 2018.
In 2019, a total of 8,730 registration applications (including five combination products) completed review and approval. Among these, 6,817 applications requiring technical review were processed (including 4,075 applications subject to technical review by the Center for Drug Evaluation and administrative approval), and 1,908 applications underwent direct administrative approval. By the end of 2019, the number of registration applications under review or awaiting review and approval had decreased from the peak of nearly 22,000 in September 2015 to 4,423 (excluding applications that had completed review but were awaiting applicants’ responses to supplement deficient submission materials). This progress has consolidated the reform achievements mandated by Document No. 44 to address the backlog of registration applications.
In 2019, among the 4,423 registration applications under review and approval or awaiting review and approval, reviews were initiated for 3,334 applications; 450 applications had completed review and were awaiting inspection; and a total of 639 applications were in various suspended status, including 290 awaiting review of associated products, 235 awaiting applicant verification of quality standards, package inserts, packaging, labels, and manufacturing processes, and 36 awaiting test reports.
Among the 6,817 registration applications that completed technical review, there were 300 traditional Chinese medicine (TCM) registration applications, 1,104 biological product registration applications, and 5,413 chemical drug registration applications, with chemical drug registration applications accounting for approximately 79% of the total volume of completed reviews.
2. Completion Status of Review for Various Registration Applications
Figure 12. Completion of Review for Various Types of Registration Applications, 2016–2019
Note: In 2019, there were five registration applications for combination medical device products; therefore, the total number of registration applications in 2019 shown in the chart above exceeds the sum of registration applications for traditional Chinese medicines, chemical drugs, and biological products.
The Center for Drug Evaluation completed the review of 1,001 Investigational New Drug (IND) applications (including one combination product involving a device), 270 New Drug Applications (NDAs) (including one combination product involving a device), and 1,664 Abbreviated New Drug Applications (ANDAs) (including three drug-device combination products). For details on the completion status of various registration application reviews from 2016 to 2019, see Figure 12.
3. Review Approval Status
In 2019, the Center for Drug Evaluation (CDE) reviewed and approved 926 Investigational New Drug (IND) applications, 164 New Drug Applications (NDA), 654 Abbreviated New Drug Applications (ANDA), and 260 applications for the consistency evaluation of oral solid dosage forms (covering 95 active ingredients and 107 generic names, as detailed in Appendix Table 1). The number of varieties increased by 66.7% year-on-year compared with 2018 (57 varieties).
Ten Class 1 innovative drugs were approved for marketing, and 58 imported originator drugs (including new indications) were approved through review. For detailed information on specific products, please refer to Appendix Tables 2 and 3.
1. Overall Situation
Figure 13 Review Completion Status of Various Types of Chemical Drug Applications in 2019
The Center for Drug Evaluation completed the review of 5,413 chemical drug registration applications, including 746 clinical trial applications (IND applications and confirmatory clinical trials), 156 New Drug Applications (NDAs), and 1,655 Abbreviated New Drug Applications (ANDAs). For details on the completion status of reviews for various types of chemical drug registration applications in 2019, see Figure 13.
2. Review Approval Status
Figure 14. Number of Chemical Drug NDAs Approved from 2016 to 2019
Table 1. Detailed Status of Completed Reviews for Various Types of Registration Applications for Chemical Drugs in 2019
Note: “Others” refers to registration applications voluntarily withdrawn by the applicant; registration applications for which the review has been completed, pending the applicant’s submission of supplementary materials; registration applications reviewed by entities other than the Center for Drug Evaluation (CDE) and submitted to the Department of Drug Registration Administration of the National Medical Products Administration (NMPA); drug-device combination registration applications submitted to the Center for Medical Device Evaluation of the NMPA; and active pharmaceutical ingredient (API)/excipient registration applications associated with withdrawn finished dosage form registrations. The same applies hereinafter.
The Center for Drug Evaluation (CDE) completed the review of 156 New Drug Applications (NDAs) for chemical drugs, of which 88 were approved. For details on the number of approved NDAs for chemical drugs from 2016 to 2019, see Figure 14; for specific details on the completion of reviews for various types of registration applications for chemical drugs in 2019, see Table 1.
The Center for Drug Evaluation (CDE) completed the review of 621 Investigational New Drug (IND) applications for chemical drugs, approving 599 IND applications. Among these, 493 IND applications for Class 1 innovative chemical drugs (covering 189 drug varieties) were approved. For details on the number of approved IND applications for Class 1 innovative chemical drugs from 2016 to 2019, see Figure 15.
Figure 15. Number of Approved Investigational New Drug (IND) Applications for Class 1 Innovative Chemical Drugs, 2016–2019
Among the 189 Class 1 chemical innovative drugs for which the Center for Drug Evaluation (CDE) approved Investigational New Drug (IND) applications, antineoplastic agents, drugs for digestive system diseases, anti-infective agents, and drugs for nervous system diseases were predominant, accounting for 70% of all approved clinical trials for innovative drugs. Figure 16 provides a detailed breakdown of the indications for Class 1 chemical innovative drugs whose IND applications were reviewed and approved in 2019.
Figure 16 Distribution of Indications for Class 1 Chemical Innovative Drugs in IND Applications Reviewed and Approved in 2019
Note: Some innovative chemical drugs have multiple indications distributed across different indication groups; therefore, the sum of the number of innovative drug varieties in each indication group in the above figure exceeds 189.
1. Overall Situation
The Center for Drug Evaluation completed the review of 300 traditional Chinese medicine (TCM) registration applications, including 17 Investigational New Drug (IND) applications, 3 New Drug Applications (NDA), and 6 Abbreviated New Drug Applications (ANDA). For detailed information on the completion status of various TCM registration application reviews in 2019, please refer to Figure 17.
Figure 17 Review Completion Status of Various Registration Applications for Traditional Chinese Medicine in 2019
2. Review and Approval Status
Figure 18 Number of Approved Traditional Chinese Medicine IND Applications and NDA Approvals, 2016–2019
The Center for Drug Evaluation (CDE) approved 15 Investigational New Drug (IND) applications for traditional Chinese medicine (TCM) and approved two New Drug Applications (NDAs) for TCM (covering two products: Shaoma Zhijing Granules and Xiao'er Jingxing Zhike Granules). For detailed information on the completion of reviews for various TCM registration applications in 2019, see Table 2. For the number of approved TCM IND applications and NDAs from 2016 to 2019, see Figure 18.
Table 2. Detailed Status of Completed Reviews for Various Registration Applications of Traditional Chinese Medicine in 2019
The Center for Drug Evaluation (CDE) approved 15 Investigational New Drug (IND) applications for traditional Chinese medicine (TCM), covering 10 therapeutic areas. Among these, cardiovascular, gastrointestinal, oncology, respiratory, and renal diseases each accounted for two applications, collectively representing 67% of the total. The specific distribution across therapeutic areas is detailed in Figure 19.
Figure 19 Distribution of Indications for Traditional Chinese Medicine IND Applications Approved in 2019
1. Overall Situation
The Center for Drug Evaluation completed the review of 1,104 biological product registration applications. Among these, 24 were Investigational New Drug (IND) applications for preventive biological products (Preventive IND Applications), 338 were IND applications for therapeutic biological products (Therapeutic IND Applications), 13 were New Drug Applications (NDA) for preventive biological products (Preventive NDAs), 95 were NDAs for therapeutic biological products (Therapeutic NDAs), and 2 were NDAs for in vitro diagnostic reagents (IVD NDAs). For detailed information on the completion status of reviews for various types of biological product registration applications in 2019, see Figure 20.
Figure 20. Review Completion Status of Various Registration Applications for Biological Products in 2019
2. Review Approval Status
The Center for Drug Evaluation approved 18 Investigational New Drug (IND) applications for preventive use and 294 IND applications for therapeutic use. It also approved 5 New Drug Applications (NDAs) for preventive use, 67 NDAs for therapeutic use, and 2 NDAs for in vitro diagnostics. For detailed information on the review completion status of various biological product registration applications in 2019, see Table 3. For the number of approved biological product IND applications and NDA approvals from 2016 to 2019, see Figure 21.
Table 3. Specific Details of the Completion of Review for Various Types of Registration Applications for Biological Products in 2019
Figure 21 Number of Biologics IND Applications Approved and NDAs Approved from 2016 to 2019
The Center for Drug Evaluation approved 312 Investigational New Drug (IND) applications for biological products; see Figure 22 for the distribution by therapeutic area.
Figure 22 Distribution of Indications for Investigational New Drug (IND) Applications for Biological Products Approved in 2019
The Center for Drug Evaluation approved 74 New Drug Applications (NDAs) for biological products; see Figure 23 for the distribution by therapeutic area.
Figure 23. Distribution of Indications for Biologic NDAs Approved in 2019
1. Overall Situation
In 2019, the Center for Drug Evaluation (CDE) completed administrative approval of 5,983 registration applications for traditional Chinese medicines, chemical drugs, and biological products. Among these, 4,075 registration applications underwent technical review and approval (including clinical trial applications, consistency evaluations, supplemental applications, re-registration applications for imported drugs, and requests for reconsideration), while 1,908 registration applications were approved through direct administrative procedures (supplemental applications not requiring technical review and applications for temporary importation).
2. Completion Status of Review and Approval
Among the 4,075 registration applications subject to review and approval by the Center for Drug Evaluation (CDE), there were 1,124 clinical trial applications (including confirmatory clinical trials), 345 applications for consistency evaluation, 2,127 supplemental applications, 471 applications for re-registration of imported drugs, and 8 requests for re-examination. In accordance with the 60-day implied permission system for clinical trials, the CDE issued 1,178 clinical trial notifications upon completion of review and approval, comprising 1,066 "Clinical Trial Approval Notices" and 112 "Clinical Trial Suspension Notices." The number of clinical trial notifications issued exceeds the 1,124 clinical trial applications requiring CDE review and approval because, during the technical review of registration applications such as Abbreviated New Drug Applications (ANDAs), applicants are sometimes required to conduct additional clinical trials; in such cases, the CDE informs the applicants via a "Clinical Trial Approval Notice."
3. Completion Status of Direct Administrative Approval
Among the 1,908 direct administrative approval registration applications undergoing technical review by the Center for Drug Evaluation (CDE), there were 1,491 supplemental applications and 417 temporary import applications.
The average approval time for 1,908 direct administrative approval registration applications processed by the Center for Drug Evaluation was 9.9 working days, with 1,905 applications completed within the statutory 20-day limit, resulting in an annual on-time completion rate of 99.8%.
1. Inclusion Status of Products Under Priority Review
In accordance with the “Opinions on Resolving the Backlog of Drug Registration Applications by Implementing Priority Review and Approval” (CFDA Drug and Chemical Administration [2016] No. 19) and the “Opinions on Encouraging Drug Innovation by Implementing Priority Review and Approval” (CFDA Drug and Chemical Administration [2017] No. 126) issued by the former China Food and Drug Administration (hereinafter referred to as the “former CFDA”), the Center for Drug Evaluation (CDE) included 253 registration applications (covering 139 varieties by generic name) in the priority review program in 2019, representing a year-on-year decrease of 19.2%, among which 52 applications were for pediatric drugs and drugs for rare diseases. For details on various types of registration applications included in the priority review program from 2016 to 2019, see Table 4.
Table 4 Registration Applications Included in the Priority Review Program, 2016–2019
Note: 1. Priority review work commenced in 2016.
2. Proportion = Number of various tasks in the current year / Total number of tasks; the same below.
Among the marketing applications included in the priority review program, new drugs with significant clinical value accounted for the largest proportion at 34%, followed by products submitted for concurrent review (28.1%). Compared with the composition of applications granted priority review in 2018, the share of new drugs with significant clinical value increased from 23% to 34%, while the proportion of products re-submitted after being refined to meet the standards of quality and therapeutic equivalence to originator drugs decreased from 16.6% to 7.9%. These data indicate a gradual decline in the number of generic drugs, with priority review resources increasingly focused on medicines that demonstrate significant clinical value, urgent clinical need, and clinical advantages.
2. Completion Status of Priority Review Products
In 2019, 143 registration applications (covering 82 varieties by generic name) were approved through the priority review pathway, accelerating their market approval. These included domestically developed Class 1 innovative drugs such as remimazolam tosylate for injection and sodium oligomannate capsules; agalsidase beta for injection for the treatment of Fabry disease, a rare disease; denosumab injection, a novel receptor activator of nuclear factor-κB ligand (RANKL) inhibitor; pegylated loxenatide injection for the treatment of diabetes; benvitimod cream for the treatment of psoriasis; and dacomitinib tablets, a targeted therapy for non-small cell lung cancer. For details on the varieties subjected to priority review in recent years, see Table 5; for the specific list of varieties, see Appendix Table 4.
Table 5 Status of Drugs Approved via Priority Review, 2016–2019
1. Overall Situation
To further strengthen service awareness and provide convenient guidance and support for applicants’ research and development innovations, the Center for Drug Evaluation (CDE) has continuously expanded communication channels and improved the efficiency and quality of interactions. This has resulted in a multi-channel, multi-tiered communication model encompassing communication meetings, consultations on general technical issues, telephone consultations, email consultations, and on-site consultations.
In 2019, the Center for Drug Evaluation (CDE) received 2,633 applications for communication meetings, a 32.8% increase from 2018, and processed 1,871 applications, a 41.1% increase from 2018. To ensure meeting quality and improve efficiency, the CDE strictly screened applications prior to meetings in accordance with the relevant requirements of the National Medical Products Administration’s “Announcement on Issuing the Administrative Measures for Communication and Exchange during Drug Research and Development and Technical Review” (Announcement No. 74 of 2018). Applications involving duplicate submissions or failure to provide valid meeting materials were rejected. For approved applications, communication meetings were convened as soon as possible within the prescribed timeframes. For applications that did not require a meeting, the CDE provided timely feedback to applicants in written form.
In 2019, 16,572 inquiries regarding general technical issues were received through online platforms, representing an 8.9% increase compared to 2018. Additionally, over ten thousand telephone consultations and several thousand email inquiries were handled, while on-site consultation services were also provided to the public. For detailed information on communication requests and general technical inquiries received in recent years, please refer to Figure 24.
Figure 24. Details of Communication and Exchange Applications and General Technical Inquiries Received in Recent Years
Note: The provision of answers to general technical questions commenced in 2017.
2. Completion Status of Communication and Meeting Requests
Table 6 Application and Processing Status of Various Types of Communication Meetings in 2019
Note: Processing rate = Number of processed applications / Total number of applications, same as below.
Among the 1,871 applications for communication meetings processed by the Center for Drug Evaluation (CDE), Type II meetings held at critical stages of drug development accounted for a significant proportion, at 71.8%. Within Type II meetings, Pre-IND meeting applications comprised the largest share, at 34.9%. For detailed information on the applications and processing status of various types of communication meetings in 2019, please refer to Table 6.
Table 7. Summary of Various Communication and Exchange Meetings Held in 2018–2019
Communication meetings were conducted via teleconference, video conference, or in-person formats. In 2019, a total of 421 communication meetings were held, representing a 30.7% increase compared with 322 meetings in 2018. Details on the number of communication meetings by type from 2018 to 2019 are presented in Table 7.
3. Responses to General Technical Questions
A total of 16,572 inquiries regarding general technical issues from the public were received on the website of the Center for Drug Evaluation. Overall, categorized by content, public inquiries mainly focused on active pharmaceutical ingredients, excipients, and packaging materials (4,152 cases) and application acceptance (1,846 cases). Categorized by drug type, inquiries were predominantly related to chemical drugs (9,743 cases), with a particular concentration in consistency evaluation of generic chemical drugs (1,386 cases) and application acceptance for chemical drugs (1,174 cases). For detailed information on responses to general technical issues, please refer to Table 8.
Table 8 Specific Responses to General Technical Questions
Note: If an applicant submits multiple general technical questions in a single submission, only one question type will be counted for statistical purposes to avoid double counting.
In 2019, the Center for Drug Evaluation initiated 1,230 inspection tasks based on technical review requirements and applicants’ compliance status, including 782 on-site pharmaceutical inspections, 446 clinical trial data verifications, and 2 pharmacology and toxicology study inspections.
In 2019, the Center for Drug Evaluation (CDE) received a total of 1,242 inspection reports, including 689 pharmaceutical on-site inspection reports, 551 clinical trial verification reports, and two pharmacology and toxicology study verification reports.
Furthermore, based on issues identified through complaints, reports, and reviews, the Center for Drug Evaluation (CDE) initiated 12 cause-specific inspections in 2019 and received eight inspection reports.
Antineoplastic Drugs:
1. Flumatinib Mesylate Tablets, the first small-molecule Bcr-Abl tyrosine kinase inhibitor with independent intellectual property rights in China, are indicated for the treatment of adult patients with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia. The approval and marketing of this product provide a better therapeutic option for such patients.
2. Dacomitinib tablets, a second-generation small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), are indicated for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations. Compared with first-generation EGFR-TKIs, this product can prolong patient survival, offering a superior therapeutic option for such patients.
3. Niraparib Tosylate Capsules, a novel highly selective poly(ADP-ribose) polymerase (PARP) inhibitor, are indicated for maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy. The approval and marketing of this product provide a new therapeutic option for such patients.
4. Denosumab Injection, a fully human monoclonal IgG2 antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), is indicated for the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. It is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. The approval and market launch of this product fill a therapeutic gap for such patients, addressing their urgent clinical needs.
5. Daratumumab injection, the world’s first anti-CD38 monoclonal antibody and the first monoclonal antibody approved for the treatment of multiple myeloma, is indicated for patients with multiple myeloma who have no further therapeutic options after prior treatment with proteasome inhibitors and immunomodulatory agents. Its approval has brought therapeutic benefits to this patient population.
6. Rituximab Injection, the first rituximab biosimilar injection and the first biosimilar drug marketed in China, is indicated for the treatment of non-Hodgkin lymphoma. Its approval has improved clinical accessibility for such patients.
7. Bevacizumab Injection, the first biosimilar of bevacizumab injection in China, is indicated for the treatment of metastatic colorectal cancer and advanced, metastatic, or recurrent non-small cell lung cancer. The approval of this product will improve the accessibility of such medications.
Anti-infective Drugs:
8. Glecaprevir/Pibrentasvir Tablets, a novel fixed-dose combination regimen for hepatitis C, are indicated for the treatment of chronic hepatitis C virus (HCV) infection with genotype 1, 2, 3, 4, 5, or 6 in adults and adolescents aged 12 to under 18 years with no cirrhosis or compensated cirrhosis. This product is included in the List of Urgently Needed Overseas New Drugs. For treatment-naïve patients without cirrhosis, the treatment duration can be shortened to 8 weeks across all genotypes. Its approval and market launch will further meet clinical needs and provide more treatment options for patients with hepatitis C.
9. Sofosbuvir, Velpatasvir, and Voxilaprevir Tablets are a fixed-dose combination formulation comprising three active ingredients: sofosbuvir, velpatasvir, and voxilaprevir. Indicated for the treatment of chronic hepatitis C virus (HCV) infection, this product is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. It provides an effective and well-tolerated salvage therapy regimen for HCV patients with prior failure of direct-acting antiviral (DAA) therapy across all genotypes, thereby addressing an unmet clinical need.
10. Lamivudine and Tenofovir Disoproxil Fumarate Tablets are a fixed-dose combination formulation of lamivudine and tenofovir disoproxil fumarate, indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, and represent the first generic version of this drug in China. The combination regimen of lamivudine tablets and tenofovir disoproxil fumarate tablets is a first-line clinical therapy for anti-HIV treatment; the approval and market launch of this product can improve patient medication adherence.
11. Ceftazidime and Avibactam Sodium for Injection, a novel β-lactamase inhibitor, is indicated for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia, and ventilator-associated pneumonia, as well as for treating infections caused by Gram-negative bacteria in adult patients with limited therapeutic options. Its market approval addresses the significant challenges posed by the growing prevalence of drug-resistant bacterial infections and meets urgent clinical treatment needs.
Cardiovascular System Drugs:
12. Bosentan Dispersible Tablets, the first specific therapeutic agent approved in China for pediatric pulmonary arterial hypertension (PAH), is included in the List of Clinically Urgent Overseas New Drugs for Pediatric Use. PAH is a progressive, life-threatening disease. Previously, there were no specific therapeutic agents available in China for pediatric PAH patients. This product represents a new dosage form developed specifically for children, and its approval and market launch have addressed the issue of drug accessibility for pediatric PAH patients.
Rheumatic Diseases and Immunomodulatory Drugs:
13. Belimumab for Injection, a recombinant fully human IgG2λ monoclonal antibody, is indicated for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who exhibit high disease activity despite conventional therapy. It is the first new drug approved globally in nearly 60 years for the treatment of SLE. Given the limited therapeutic options currently available for SLE, the approval of this product addresses unmet clinical needs in this patient population.
14. Adalimumab Injection, the first adalimumab biosimilar in China, is indicated for the treatment of autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis in adult patients. Its market approval will enhance clinical accessibility to this class of drugs and effectively reduce the financial burden on patients.
Drugs for the Nervous System:
15. Lacosamide Tablets, a novel antiepileptic drug, are indicated for adjunctive therapy of partial-onset seizures in epilepsy patients aged 16 years and older. As the first generic version approved in China, its market authorization enhances medication accessibility and convenience for this patient population.
16. Midazolam Buccal Mucosal Solution is the first buccal mucosal solution approved in China for the treatment of acute seizures in children, classified as a pediatric medication. Pediatric seizures often occur suddenly, making administration via intravenous injection, intramuscular injection, or rectal routes challenging. The buccal mucosal route addresses the limitations of these conventional methods. The approval and market launch of this product provide a new and more convenient administration option for such patients.
Analgesics and Anesthesiology Drugs:
17. Chloral hydrate enema, a central sedative indicated for sedation and hypnosis prior to pediatric examinations or procedures, as well as for anticonvulsant therapy under monitoring conditions, is included in the first batch of the List of Pediatric Drugs Encouraged for Research, Development, and Application. This product features a dosage form suitable for pediatric use; its market approval fills the gap in China where no chloral hydrate formulations for pediatric procedural sedation were previously available, thereby addressing the urgent clinical needs of pediatrics in China.
Dermatology and Otorhinolaryngology Medications:
18. Benvitimod Cream, the world’s first globally innovative drug for the treatment of psoriasis with independent intellectual property rights in China, features a novel structure and a novel mechanism of action. It is indicated for the topical treatment of mild-to-moderate stable plaque psoriasis in adults. Its market approval provides clinicians with a new, safe, and effective therapeutic option.
19. Secukinumab Injection is the first interleukin-class drug approved in China for the treatment of moderate-to-severe psoriasis and is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. Compared with TNF-α inhibitors, this product demonstrates superior efficacy, and its approval provides patients with a therapeutic option featuring a novel mechanism of action.
Orphan Drugs:
20. Elosulfase Alfa Injection is the first and only enzyme replacement therapy approved in China for the treatment of Mucopolysaccharidosis Type IVA (MPS IVA, Morquio A Syndrome), a rare disease. It is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. Mucopolysaccharidosis is a life-threatening condition with no effective treatments previously available in China; the approval of this product fills the therapeutic gap for patients with this disease in the country.
21. Agalsidase beta for injection is a long-term enzyme replacement therapy drug for the treatment of Fabry disease, a rare disorder, and is included in the list of urgently needed overseas new drugs for clinical use. Fabry disease is a life-threatening condition with no effective treatments currently available in China; it has been listed in China’s first batch of Rare Diseases Catalogue. The approval and market launch of this product fill the therapeutic gap for such patients in China.
22. Nusinersen Sodium Injection is the first and only drug approved in China for the treatment of spinal muscular atrophy (SMA), a rare disease, and is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. This product effectively addresses the urgent clinical need for effective therapeutic options for SMA in China, where previously no effective treatments were available.
23. Edaravone and Sodium Chloride Injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS), a rare disease, and is included in the List of Urgently Needed Overseas New Drugs for Clinical Use. This product effectively addresses the urgent clinical need for effective therapeutic options for ALS, which currently lacks such treatments in China.
Prophylactic Biological Products (Vaccines):
24. The 13-valent pneumococcal polysaccharide conjugate vaccine, the first domestically produced pneumococcal conjugate vaccine with independent intellectual property rights, is indicated for infants and children aged 6 weeks to 5 years (before their 6th birthday) for the prevention of infectious diseases caused by 13 serotypes of Streptococcus pneumoniae, including serotypes 1 and 3. As the second vaccine globally for the prevention of pneumonia in infants and children, its market launch has improved the accessibility of such vaccines and better meets public demand.
25. Recombinant Zoster Vaccine (CHO Cell), indicated for the prevention of herpes zoster in adults aged 50 years and older, is included in the List of Clinically Urgent Overseas New Drugs. The risk of herpes zoster increases with age, and its complications severely impair patients’ normal work and daily life. Currently, there is a lack of effective preventive and therapeutic measures for this disease in China. The approval and marketing of this product further meet the clinical medication needs of the public, particularly among the aging population in China.
26. Bivalent Human Papillomavirus Vaccine (E. coli), the first domestically produced human papillomavirus (HPV) vaccine in China, is indicated for females aged 9–45 years to prevent diseases associated with HPV types 16 and 18. For females aged 9–14 years, a two-dose immunization schedule administered at months 0 and 6 may also be adopted. This product will further alleviate the supply-demand imbalance of HPV vaccines in China and help meet the clinical needs of Chinese women for HPV vaccination.
New Traditional Chinese Medicine Drugs:
27. Shaoma Zhijing Granules, a new traditional Chinese medicine (TCM) compound formulation composed of 11 ingredients including White Peony Root and Gastrodia Elata, is indicated for pediatric use. It is used to treat Tourette syndrome and chronic tic disorders in patients with TCM pattern differentiation of liver hyperactivity generating wind and internal disturbance by phlegm-fire. This product can significantly improve motor tics, vocal tics, and social function impairment in pediatric patients. The incidence of adverse reactions in the nervous and psychiatric systems is significantly lower than that of tiapride hydrochloride tablets, a positive control drug among marketed products. It provides a safer and more effective therapeutic option for pediatric patients, especially those with mild-to-moderate conditions, thereby meeting patient needs and addressing clinical accessibility.
28. Xiao'er Jingxing Zhike Granules are a new traditional Chinese medicine (TCM) compound formulation composed of 12 ingredients, including Schizonepetae Herba and Semen Armeniacae Amarum. Designed for pediatric use, it has the functions of “dispersing wind and cold, ventilating the lungs to clear heat, and resolving phlegm to relieve cough.” It is indicated for the treatment of mild bronchitis in children caused by exogenous wind-cold transforming into heat. This product demonstrates significant efficacy in improving main symptoms such as cough and sputum production, as well as in enhancing TCM syndrome scores and clinical recovery rates. With few adverse reactions, it provides a new, safe, and effective therapeutic option for pediatric patients with acute bronchitis.
(1) Accelerate the review of overseas new drugs urgently needed for clinical use
In continued implementation of the spirit of the State Council’s executive meetings, and to fulfill the requirements for accelerating the review of urgently needed new drugs already marketed abroad—thereby improving public access to medications—the Center for Drug Evaluation (CDE), building upon the initially identified list of 48 products, organized experts to select additional urgently needed new drug candidates and finalized a second batch comprising 26 products. For each product included on the list of urgently needed overseas new drugs, the CDE engaged in individual communications with the relevant companies, proactively disseminating national policies aimed at expediting the review and approval of such drugs. Guidance and assistance were provided to companies facing difficulties to help them submit registration applications as soon as possible. Meanwhile, the CDE clarified the work procedures and documentation requirements for the review and approval of urgently needed new drugs, accepted overseas clinical trial data, established dedicated review channels, and accelerated the review process.
Through the aforementioned measures, in 2019, the Center for Drug Evaluation (CDE) approved 16 clinically urgent drugs for the treatment of rare diseases, representing a 60% increase compared to 2018. All reviews were completed within the prescribed timeframes: reviews for rare disease drugs were completed within three months, and reviews for other clinically urgent drugs were completed within six months, significantly narrowing the gap between the market availability of these urgently needed overseas new drugs in China and abroad. To date, 26 products have been approved for marketing or have completed technical review; 14 products are undergoing technical review; 6 products are having their documentation organized in preparation for marketing application submission; 11 products are having their documentation organized but have not yet submitted registration applications; 11 products currently have no plans for marketing application submission; and contact with the marketing authorization holders of 6 products could not be established. For details, see Appendix Table 5.
(II) Vigorously Promote the Consistency Evaluation of Generic Drugs
First, standardize the selection process for reference listed drugs (RLDs) by formulating and issuing the "Procedures for the Selection and Determination of Reference Listed Drugs for Generic Drugs" through the National Medical Products Administration (NMPA). Since the initiation of the RLD selection work, 22 batches comprising 1,899 product specifications have been released (including 402 specifications for injectable RLDs), with 3 batches totaling 748 specifications released in 2019. Second, actively review domestic-unique varieties; following expert deliberation and public consultation, publish the "Recommendations for the Evaluation of Domestic-Unique Varieties" on the website of the Center for Drug Evaluation (CDE) to guide enterprises in conducting evaluations. Third, strengthen information disclosure and communication by launching a "Generic Drug Consistency Evaluation Column" on the CDE website, timely disclosing package inserts, enterprise research reports, and bioequivalence (BE) trial data for products that have passed consistency evaluation. Organize technical seminars on consistency evaluation, conduct training and publicity on relevant policies and technical requirements, further enhance communication with the industry, and provide consultation services and guidance for enterprise submissions through consultation days, the Applicant Window, telephone, and official documents. Fourth, conduct extensive surveys and discussions with experts and industry stakeholders to formulate the "Technical Requirements for Consistency Evaluation of Marketed Chemical Injections," "Requirements for Submission Materials for Consistency Evaluation of Marketed Chemical Injections," and "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections (Special Injections)." These documents clarify the overall research approach and technical requirements for the consistency evaluation of generic chemical injections, enabling enterprises to better conduct related research. Fifth, in 2019, the filing platform for bioequivalence trials of chemical drugs collected 442 records, and the filing platform for bioequivalence trials for generic drug consistency evaluation collected 737 records.
(III) Continuously Promote the Reform of the Review and Approval System
1. Implement risk management during clinical trials
The newly revised Drug Administration Law of 2019 explicitly states that “the State shall establish a pharmacovigilance system to monitor, identify, assess, and control adverse drug reactions and other harmful reactions associated with medication use.” “Where safety issues or other risks are identified during clinical trials of drugs, the trial sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the national drug regulatory authority. Where necessary, the national drug regulatory authority may order adjustments to the clinical trial protocol, suspension, or termination of the clinical trial.”
In 2019, the Center for Drug Evaluation (CDE) received 117,140 individual case safety reports of suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials from 164 domestic and international R&D enterprises, involving 432 investigational drugs and 43,131 cases. Among these, 11,062 SUSAR reports originated from within China, involving 3,166 cases. Since the electronic submission pathway for Development Safety Update Reports (DSURs) was opened on April 26, 2019, a total of 585 reports have been received.
To better control risks in drug clinical trials, the Center for Drug Evaluation (CDE) has undertaken the following initiatives: First, it has strengthened the monitoring, review, and handling of safety reports during the clinical trial period, gradually established and clarified the division of responsibilities among all parties involved in risk monitoring and management, standardized relevant working mechanisms and procedures, and systematically carried out risk control activities during the clinical development of drugs. Second, it has developed and implemented targeted monitoring plans for high-risk drugs in clinical trials (such as CAR-T cell therapy products). For 13 drug products with significant safety risks identified in clinical trials, the CDE has provided further recommendations on risk control measures, actively engaged in risk communication with applicants, and enhanced risk control in clinical trials by urging applicants to improve their risk management strategies (e.g., amending clinical trial protocols, informed consent forms, and investigator brochures, or advising applicants to voluntarily suspend clinical trials), thereby effectively safeguarding the safety of trial participants.
2. Optimize Compliance Review and Inspection Procedures
First, optimize and improve the compliance review system by exploring the establishment of a dual-track risk control model, wherein evaluation is based on product-specific risk factors and compliance oversight is based on applicant-specific compliance risk factors. Second, advance the development of a compliance information database for R&D and manufacturing entities, promote the parallel conduct of evaluation and inspection activities, and move the initiation of inspections forward to the specialized evaluation stage. Third, continuously strengthen the synchronized execution and procedural coordination between evaluation and inspection/testing activities, promote the digitalization of coordination efforts for inspections and testing, and establish a regular communication and exchange mechanism between evaluation and inspection/testing teams.
3. Implement joint review and approval of raw materials, excipients, packaging materials, and drug products
In accordance with the National Medical Products Administration’s “Announcement on Further Improving the Linked Review, Approval, and Supervision of Drugs” (No. 56 of 2019, hereinafter referred to as “Announcement No. 56”), the Center for Drug Evaluation (CDE) has enhanced the registration acceptance system and technical review system for active pharmaceutical ingredients (APIs), updated API registration forms and related administrative licensing documents, and enabled separate review and approval for APIs used in generic drug products already marketed in China through the registration system. A total of 15,538 API, excipient, and packaging material products meeting the requirements of Announcement No. 56 have been pushed to the registration platform and marked with an “A” status. The registration platform for APIs, pharmaceutical excipients, and packaging materials publicly lists 26,424 products in total, including 12,541 APIs, 3,066 pharmaceutical excipients, and 10,817 packaging materials.
4. Advance the work on the Catalogue of Marketed Drugs in China
Since the initiation of the *Catalogue of Marketed Drugs in China*, a total of 1,055 drug products (counted by dosage form and specification, as below) have been included. Among these, there are 484 imported original research drugs, 336 drugs that have passed the consistency evaluation of quality and efficacy for generic drugs, 105 generic drugs approved under the new chemical drug registration classification, 21 innovative drugs, and 109 other drugs. In 2019, a total of 430 dosage forms and specifications were included, representing a year-on-year increase of 1.42% compared to 2018 (424 dosage forms and specifications).
(4) Establishing a Science-Based Management System for the Drug Review Process
In accordance with the work arrangements of the State Administration for Market Regulation and the National Medical Products Administration, and to continuously improve and optimize the review and approval processes, enhance review efficiency, and comprehensively elevate the standards of drug evaluation work, the Center for Drug Evaluation (CDE) has adhered to a people-centered development philosophy. The CDE established a Leading Group for Scientific Management Systems and an Efficiency Office, upholding the principles of comprehensive research, pilot-first implementation, and iterative improvement during trials. Through various approaches—including on-site visits and investigations, full staff participation, and collective brainstorming—the CDE has decomposed and refined existing processes, optimized and upgraded them, and proposed targeted reform measures. It has actively promoted the construction of a science-oriented management system for drug evaluation processes.On the basis of strengthening top-level design, researching pilots, and supervising their implementation, the CDE has employed institutional development and efficiency monitoring as effective means to ensure that all reform measures are fully implemented. By integrating internal oversight mechanisms into the entire process of exercising evaluation authority and strengthening efficiency supervision, the CDE has ensured the implementation of various reform measures and achieved initial results. This initiative has provided strong support for improving review efficiency, standardizing review criteria, and enhancing the quality of drug evaluation reports.
(V) Solidly Advance the Development of Scientific Foundations for Review and Evaluation
1. Deeply involved in the formulation and revision of pharmaceutical laws and regulations
On the basis of actively participating in the formulation and revision of laws and regulations such as the Drug Administration Law and the Vaccine Administration Law, the Center for Drug Evaluation has made every effort to carry out the formulation and revision of the 35 supporting documents for the newly revised Measures for the Administration of Drug Registration.
2. Actively Promote the Continued In-Depth Implementation of ICH Work
We have made every effort to align China’s drug review and approval system with international standards and actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) international coordination and the translation and implementation of its guidelines. First, we engaged deeply in ICH topic coordination by dispatching 53 experts to 30 ICH working groups, participating in 20 meetings of the ICH Assembly and Management Committee, organizing 263 ICH-related expert meetings, and handling 327 ICH-related matters. Second, we prioritized the implementation of ICH Level 3 guidelines by assessing their domestic implementation status, assisting the National Medical Products Administration in issuing announcements on the applicability and recommended application of 43 ICH Level 3 guidelines, and coordinating the translation of the original texts of these guidelines. Third, we organized ICH training initiatives; the ICH Office worked closely with the ICH Secretariat and third-party organizations to conduct 16 training sessions on ICH guidelines, reaching 2,600 participants. These efforts achieved the goal of training regulatory authorities while expanding publicity and influence within the industry.
3. Strengthen and refine the construction of technical standards for review and evaluation
We have established a review standard system centered on technical guidelines to unify review criteria, enhance the quality and efficiency of reviews, and reduce discretionary authority in the review process. In 2019, 33 technical guidelines, including the "Technical Guidelines for Clinical Trial Endpoints in Advanced Non-Small Cell Lung Cancer," were released for public comment. Among these, nine guidelines were developed to promote the inheritance of Traditional Chinese Medicine (TCM) and the research and development of new drugs, such as the "Technical Guidelines for Quality Standard Research on New TCM Drugs." In 2019, eight technical guidelines were either issued by or submitted to the National Medical Products Administration (NMPA) (see Appendix Table 6 for details). To facilitate the implementation of the "Provisions for Drug Registration," the Center for Drug Evaluation (CDE) initiated the formulation and revision of five technical guidelines. A scientific and efficient system of technical guidelines is gradually taking shape, based on the principles of encouraging innovation, supporting R&D, and standardizing the review process.
4. Scientifically Coordinate the Development of a Quality Management System for Review and Evaluation
Further promote the integration and mutual reinforcement of drug evaluation and the quality management system. Organically integrate system documents, such as the Quality Manual, with laws and regulations related to drug evaluation, ensuring that all requirements of the quality system are effectively implemented in the various operations of the Center for Drug Evaluation (CDE). On one hand, centering on quality objectives, scientifically utilize information system tools to institutionalize routine evaluation supervision and management. On the other hand, guided by practical issues identified during the evaluation process, conduct specialized internal audits in accordance with quality system requirements; place high importance on satisfaction levels and work suggestions from the National Medical Products Administration (NMPA) and applicants regarding the CDE’s evaluation services; promptly formulate improvement measures and continuously oversee their implementation. This will enhance the professionalism of the quality management system in drug evaluation work, thereby ensuring and improving the quality and efficiency of drug evaluation.
5. Optimize and Enhance the Development of the eCTD System
Strengthen the development of information systems for regulatory review and comprehensively advance the construction of the Electronic Common Technical Document (eCTD) management system for pharmaceuticals (hereinafter referred to as the “eCTD System”). First, formulate technical specifications, submission guidelines, and other technical documents for eCTD to clarify the technical requirements for applicants in preparing documentation and submitting registration applications. Second, complete system testing with ten domestic and international pharmaceutical companies, optimize system functions and workflows, and accumulate practical operational experience for the launch and operation of the eCTD System. Third, complete the modification and integration of supporting systems associated with the eCTD project, achieving end-to-end electronic management of the entire drug registration process, including application acceptance and regulatory review. Fourth, establish a dedicated eCTD portal to provide high-quality services that facilitate communication and engagement with applicants.
(6) Continuously Enhance the Capabilities of the Review Team
Solidly advance the training of reviewers, continuously promote the institutionalization, standardization, systematization, and specialization of training work at the Center for Drug Evaluation (CDE), further improve the management system for reviewer training, and formulate institutional documents such as the CDE’s “Employee Training Management Measures.” Conduct pre-service training, continuing education, appointment training, and in-service degree and diploma education for employees in areas including political theory, integrity and confidentiality education, conflict of interest prevention, laws and regulations, professional theoretical knowledge related to review, review practices, practical operations, professional theoretical knowledge related to comprehensive management, and comprehensive quality and capabilities. Organize practical training for selected senior reviewers and fresh graduates to broadly expand their perspectives on review work, continuously enhance review capabilities, and steadily build a high-caliber workforce for drug evaluation. Continue to deepen communication and exchanges with international organizations and regulatory agencies such as the World Health Organization, the U.S. Food and Drug Administration, and the Danish Medicines Agency; strengthen cooperation with domestic universities and research institutes; carry out academic interactions and exchanges; keep pace with the forefront of industry development; and serve the innovative development of the pharmaceutical industry.
In 2019, certain progress was made in drug review work, yet several issues persisted: First, the staffing structure and capabilities of the Center for Drug Evaluation (CDE) were insufficient to meet the demands of innovative drug research and development, making the modernization of review capacity a formidable task for the development of the review workforce. Second, with the implementation of the “Two Laws and One Measure,” substantial adjustments to supporting documents and systems remained to be completed urgently; under the requirements of higher review standards, greater efforts were needed to ensure the quality and efficiency of reviews. Third, there remained a gap between applicants’ expectations and the actual performance in areas such as the transparency of review information disclosure and the capacity to conduct face-to-face communication meetings.
In 2020, the Center for Drug Evaluation will closely align with the work arrangements of the National Medical Products Administration, focusing on the following key tasks:
(I) Actively promote the establishment of a comprehensive regulatory framework
Implement the newly revised Drug Administration Law, Vaccine Administration Law, and Measures for the Administration of Drug Registration; accelerate the formulation and revision of regulatory frameworks; continue to draft supporting documents for the Measures for the Administration of Drug Registration based on actual conditions; strengthen the publicity and implementation of laws and regulations by continuously carrying out outreach and interpretation of the “Two Laws and One Measure” and related supporting rules; coordinate and ensure a smooth transition and alignment between the old and new Measures for the Administration of Drug Registration, guaranteeing that all review and evaluation tasks proceed without interruption, fragmentation, or disorder.
(II) Continuously Deepen the Reform of the Review and Approval System
Further deepen the reform of the drug review and approval system, enhance the quality of review services, improve the management systems and processes for review projects, and establish a sound mechanism for expedited review of drugs seeking market approval. Continue to uphold the baseline of time-bound reviews, implement dynamic, continuous management and coordination of review timelines, and ensure that registration applications do not accumulate. Accelerate the review and approval of overseas new drugs urgently needed for clinical use, drugs for rare diseases, pediatric drugs, and drugs for major infectious diseases; encourage synchronized research, development, and filing of new drugs both domestically and internationally; promote the timely market launch of new drugs at home and abroad; and continuously foster innovation in drug development. Solidly advance the consistency evaluation of quality and efficacy for generic drugs, carry out consistency evaluations for chemical injectables, and continuously promote consistency evaluations for oral solid dosage forms of chemical generic drugs. Improve the selection procedures and requirements for reference listed drugs.
(III) Continuously Improve the Drug Review and Approval Support Mechanism
Establish a review and management system centered on clinical value, improve the technical review system led by evaluation and supported by inspections and testing, and promote the modernization of the review system; accelerate the informatization of the review process, continue testing the eCTD system, and achieve electronic submission and review in accordance with eCTD requirements as soon as possible; continue to establish the Expert Advisory Committee, formulate detailed meeting procedures, and develop relevant working standards; deepen international cooperation, strengthen exchanges and collaboration among regulatory authorities, and participate extensively in ICH international harmonization and guideline development; continuously improve the review standard system centered on guidelines to unify review criteria; strengthen the construction of an integrated pharmacovigilance work model and system, and improve the pharmacovigilance mechanism throughout the product lifecycle.
(4) Encourage and support the inheritance, innovation, and development of traditional Chinese medicine
Implement the "Opinions on Promoting the Inheritance, Innovation, and Development of Traditional Chinese Medicine" issued by the CPC Central Committee and the State Council, strengthen top-level design, establish a registration and evaluation system that integrates TCM theories, human use experience, and clinical trials, develop evaluation standards suited to the safety, efficacy, and quality controllability of traditional Chinese medicines, and improve the priority review system; in accordance with the arrangements of the National Medical Products Administration, formulate and refine technical guidelines that reflect the characteristics of traditional Chinese medicine; encourage the development and application submission of compound preparations derived from ancient classic prescriptions, and promote the inheritance, innovation, and development of traditional Chinese medicine.
(V) Continuously advance the construction of a process-oriented scientific management system
Drawing on lessons learned from preliminary research and pilot programs, we will continue to advance the development of a process-oriented scientific management system. In conjunction with the implementation of superior laws and supporting documents, we will ensure that reform measures for system development deliver tangible results. We will strengthen institutional frameworks and IT infrastructure, continuously explore and summarize experiences through research and pilot initiatives, further standardize processes, and safeguard the sustainability of various reform implementations. We will intensify performance monitoring efforts, focusing on identifying and resolving potential risks, thereby continually enhancing the scientific management level of reviews. Leveraging the outcomes of the scientific management system for review processes and the quality management system, we will gradually establish and refine Good Review Practice (GRP) standards.
(6) Persist in advancing the deepening of the “decentralization, regulation, and service” reform
Deepen the reform of "delegating power, improving regulation, and upgrading services," enhance service awareness, improve communication and service mechanisms, and promote innovative development in the pharmaceutical industry; thoroughly implement the Regulations on the Disclosure of Government Information, proactively disclose key information related to review and approval; make information on application acceptance and approval publicly available to guide applicants in conducting R&D and submitting applications in an orderly manner; strengthen publicity and guidance for the industry, focus on addressing common issues, and improve communication efficiency with applicants.
(7) Continue to Strengthen the Development of Review Personnel Teams
Unblock career development pathways for reviewers; further improve the training system, continuously enhance the pertinence and systematic nature of training, and carry out various training programs including professional knowledge in review, English language, and comprehensive management; conduct supplementary recruitment to introduce scarce professional talents in fields such as clinical medicine and statistics.
"If you can renew yourself one day, do so every day, and keep renewing." Strive diligently throughout the day and advance with the times. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, the Center for Drug Evaluation (CDE) adheres to a people-centered development philosophy, fully implements the "four strictest" requirements, and comprehensively enforces the Drug Administration Law and the Vaccine Administration Law. The CDE continues to deepen reforms of the drug review and approval system, improve incentive mechanisms for pharmaceutical R&D and innovation, stimulate innovation and competitiveness, and consistently promote high-quality development of the pharmaceutical industry. It actively advances the modernization of the drug review system and capabilities, striving to build an authoritative, internationally influential, and publicly trusted drug regulatory agency. By accelerating the market launch of innovative and high-quality drugs, the CDE aims to meet the public’s urgent medication needs, safeguard their rights to access medicines, and faithfully fulfill its mission of protecting and promoting public health.