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Implementation Regulations of China's New Drug Administration Law Enforced! Effective from May 15

Jan 28, 2026 09:58 CST Updated 09:58

Decree of the State Council of the People's Republic of China

No. 828

The Implementing Regulations of the Drug Administration Law of the People's Republic of China have been revised and adopted at the 76th executive meeting of the State Council on December 31, 2025, and are hereby promulgated, to be implemented from May 15, 2026.

PremierLi Qiang

January 16, 2026


Regulations for the Implementation of the Drug Administration Law of the People's Republic of China

(Published on August 4, 2002, by Decree No. 360 of the State Council of the People's Republic of China; First revised on February 6, 2016, according to the "Decision of the State Council on Amending Some Administrative Regulations"; Second revised on March 2, 2019, according to the "Decision of the State Council on Amending Some Administrative Regulations"; Third revised on December 6, 2024, according to the "Decision of the State Council on Amending and Abrogating Some Administrative Regulations"; Fourth revised on January 16, 2026, by Decree No. 828 of the State Council of the People's Republic of China)


Chapter One: General Provisions


Article 1According to the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the Drug Administration Law), these regulations are formulated.

Article 2Engaging in the research, production, operation, use, and supervision of pharmaceuticals must adhere to the principle of prioritizing people's health, follow scientific laws and ethical principles, and comprehensively control risks.

Article 3The state improves the drug innovation system, supports drug research and innovation oriented by clinical value, encourages the research and creation of new drugs, and supports the clinical promotion and use of new drugs; promotes the inheritance and innovation of traditional Chinese medicine, and gives full play to the role of traditional Chinese medicine in prevention, medical treatment and health care; promotes the R&D innovation of generic drugs and enhances the quality and efficacy of generic drugs.

Article 4The department in charge of drug supervision and administration under the people's governments at or above the county level (hereinafter referred to as the drug supervision and administration department) is responsible for drug supervision and administration. Other relevant departments under the people's governments at or above the county level are responsible for the supervision and administration related to drugs within their respective responsibilities.

Article 5The competent departments of the State Council for industry and information technology, the competent departments of the State Council for commerce, etc., according to their respective responsibilities and based on the national economic and social development plan as well as the development status of the pharmaceuticals industry, formulate relevant plans and industrial policies for the development of the national pharmaceuticals production and circulation industries. They promote the structural adjustment and technological innovation of the pharmaceuticals industry, enhance the resilience and safety level of the industrial chain, and facilitate the high-quality development of the pharmaceuticals industry. The drug regulatory department of the State Council collaborates with the competent departments of the State Council for industry and information technology, the competent departments of the State Council for commerce, etc., to implement the relevant plans and industrial policies for the development of the national pharmaceuticals industry.


Chapter Two: Pharmaceutical Research and Registration


Article 6Engaging in drug research and development activities should comply with the Good Laboratory Practice (GLP) for non-clinical drug studies and the Good Clinical Practice (GCP) for drug clinical trials, ensuring that records and data are true, accurate, complete, and traceable.

Article SevenNon-clinical safety evaluation studies conducted for the purpose of applying for drug registration shall be carried out by non-clinical safety evaluation institutions that have been qualified. Applications for qualification as a non-clinical safety evaluation institution shall be submitted to the drug regulatory department under the State Council, along with documentation proving compliance with Good Laboratory Practice (GLP) for non-clinical studies. The drug regulatory department under the State Council shall organize a review and make a decision within 20 working days from the date of accepting the application. If the applicant meets the specified conditions, permission will be granted and a qualification certificate will be issued; if the applicant does not meet the specified conditions, permission will be denied, and reasons will be provided in writing.

The validity period of the qualification certificate for non-clinical drug safety evaluation institutions is 5 years. Upon expiration, if continued implementation of non-clinical drug safety evaluation research is required, an application for reissuance of the qualification certificate must be submitted.

Article EightThe sponsor of a drug clinical trial shall select a drug clinical trial institution and researchers with corresponding capabilities, and fulfill responsibilities such as the protection of subjects, management of clinical trial drugs, clinical trial data management, and risk management.

The preparation of investigational drugs should comply with the relevant requirements of Good Manufacturing Practice (GMP) for pharmaceuticals.

Sponsors of drug clinical trials and drug clinical trial institutions shall not charge subjects for costs related to clinical trials.

Article 9According to the provisions of the first paragraph of Article 19 of the Drug Administration Law, applications for changes to the sponsor of a drug clinical trial shall be submitted to the drug regulatory department of the State Council. The drug regulatory department of the State Council shall review and make a decision within 20 working days from the date of accepting the application.

Article 10If the purpose of conducting drug research and development activities overseas is to apply for drug registration, compliance with the Drug Administration Law, this Regulation, and other relevant laws, regulations, rules, standards, and norms is required; research data obtained overseas that meets the relevant provisions of the drug regulatory authority under the State Council can be used for applying for drug registration.

Article 11For the purpose of applying for drug registration, the import of control drugs and samples required for research or testing shall be approved by the drug regulatory department of the State Council; however, clinical trial drugs specified in the approval document for drug clinical trials can be imported based on the approval document. The drug regulatory department of the State Council shall review and make a decision within 20 working days from the date of accepting the application.

Article 12The development of chemical generic drugs should follow the technical requirements formulated by the drug regulatory department under the State Council, scientifically selecting reference drugs for comparative studies; if there are reference preparations determined by the drug regulatory department under the State Council, such reference preparations should be selected as the control drugs for comparative studies.

Article 13The development of traditional Chinese medicine (TCM) should be guided by TCM theory, and the safety and efficacy of TCM should be comprehensively evaluated based on TCM theory, human experience with TCM, clinical trial data, etc. The evaluation of TCM efficacy should correspond to its clinical positioning and reflect the characteristics of TCM.

Article 14The research, development, and production of traditional Chinese medicine should ensure the stability of the source and quality of medicinal materials and the sustainable utilization of resources, avoiding any adverse impact on the ecological environment; if it involves wildlife or plants, it must comply with relevant national regulations.

Article 15For the registration application of drugs, the drug supervision and administration department of the State Council will conduct evaluation and approval in accordance with Article 25 of the Drug Administration Law.

To support drug research and innovation driven by clinical value, the drug regulatory department of the State Council may adopt procedures such as breakthrough therapy designation, conditional approval, priority review and approval, and special approval for eligible drug registration applications to accelerate drug marketing.

The drug supervision and administration department of the State Council establishes and improves the review and approval, inspection and testing, and standard management systems that conform to the characteristics of traditional Chinese medicine.

Article 16When the drug regulatory department of the State Council approves drugs, it reviews and approves chemical active pharmaceutical ingredients (APIs) at the same time. If the requirements are met, it issues a drug registration certificate for the drug and a chemical API approval certificate for the chemical API. For the replication of chemical APIs used in already registered drugs, an application for review and approval can also be directly submitted to the drug regulatory department of the State Council; if the requirements are met, a chemical API approval certificate will be issued. When reviewing and approving chemical APIs, the drug regulatory department of the State Council simultaneously verifies the quality standards, production processes, and labels of the chemical APIs.

To transfer a drug registration certificate or an approval certificate for chemical raw materials, an application must be submitted to the drug regulatory department under the State Council. The drug regulatory department under the State Council shall review and make a decision within 20 working days from the date of accepting the application.

Article 17The validity period of the drug registration certificate and the approval certificate for chemical raw materials is 5 years. If it is necessary to continue marketing after the expiration, re-registration should be applied for.

Marketing authorization holders of pharmaceuticals and chemical API manufacturers shall apply for re-registration to the drug regulatory department of the provincial people's government where they are located; if the marketing authorization holders of pharmaceuticals and chemical API manufacturers are overseas enterprises, they shall apply for re-registration to the drug regulatory department of the State Council.

Article 18If it meets the non-prescription drug registration scenarios stipulated by the State Council's drug regulatory authority, the drug registration applicant can directly submit a non-prescription drug registration application.

Registered prescription drugs that the marketing authorization holder considers suitable for over-the-counter (OTC) management can apply to the State Drug Administration Department of the State Council for conversion to OTC drugs. For registered OTC drugs, if the marketing authorization holder determines, based on adverse reaction monitoring and post-marketing evaluation results, that they are not suitable for OTC management, they must apply to the State Drug Administration Department of the State Council for conversion to prescription drugs. After organizing an evaluation and determining that the requirements are met, the State Drug Administration Department of the State Council will decide to convert prescription drugs to OTC drugs or OTC drugs to prescription drugs, and make a public announcement.

The drug regulatory department of the State Council can decide to convert over-the-counter drugs into prescription drugs based on the need to ensure public drug safety after organizing evaluations.

Article 19China promotes the improvement of drug standards and continuously enhances the quality level of drugs.

The drug quality standard approved by the drug regulatory department of the State Council is the drug registration standard. The drug registration standard shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than the corresponding national drug standards. The marketing authorization holder of a drug shall evaluate the drug registration standard based on the formulation and revision of the national drug standards. If revision is needed, the holder shall promptly revise it and submit a change application or file a record or report according to the regulations of the drug regulatory department of the State Council.

Article 20The development of pharmaceuticals and the application for drug registration should use national drug reference standards and control substances. In the absence of national drug reference standards and control substances, the drug registration applicant must submit the raw materials and related technical data used in the drug quality standard research to the drug inspection institution established or designated by the State Council's drug regulatory department. The drug inspection institution shall legally develop and standardize national drug reference standards and control substances.

The drug inspection institutions set up or designated by the drug supervision and administration department of the State Council shall strengthen the research and development capacity of national drug reference standards and control substances, and ensure the supply of national drug reference standards and control substances.

Article 21The state supports the research, development, and innovation of medicines for children and rare diseases.

For new varieties of pediatric drugs, pediatric drugs adopting new dosage forms or new specifications, and drugs with added pediatric indications, those that meet the conditions will be granted a market exclusivity period of no more than 2 years.

For eligible rare disease treatment drugs, if the marketing authorization holder commits to ensuring drug supply, a market exclusivity period of up to 7 years will be granted. If the marketing authorization holder fails to fulfill the commitment to ensure drug supply, the market exclusivity period will be terminated.

The specific conditions and methods for granting market exclusivity periods shall be formulated by the drug regulatory department of the State Council.

Article 22The State protects the undisclosed test data and other data independently obtained and submitted by the marketing authorization holders of drugs containing new chemical components and other eligible drugs. No person shall make any improper commercial use of such undisclosed test data and other data.

The protection period for the data specified in the preceding paragraph shall not exceed six years from the date of drug registration. During the protection period, other applicants who use the data specified in the preceding paragraph to apply for drug registration without the consent of the drug marketing authorization holder will not be granted permission; however, this does not apply if the other applicant submits independently obtained data.

Except in the following circumstances, the drug regulatory department shall not disclose the data specified in the first paragraph of this article:

(1) Needs of public interest;

(II) Measures have been taken to ensure that such data will not be improperly used for commercial purposes.

The specific measures for the protection of the data stipulated in the first paragraph of this article shall be formulated by the drug regulatory department of the State Council.


Chapter Three: Marketing Authorization Holder for Pharmaceuticals


Article 23The marketing authorization holder of pharmaceuticals shall establish and improve the quality assurance system for pharmaceuticals, set up an independent quality management department, and appoint a production manager, a quality manager, and a qualified person for quality. The qualified person for quality shall independently perform the duties of drug marketing release.

Article 24Marketing authorization holders of pharmaceuticals shall comply with the Good Pharmacovigilance Practice, establish and improve the pharmacovigilance system, monitor adverse drug reactions and other harmful reactions related to medication, and establish mechanisms for risk identification, assessment, and control. Pharmaceutical distribution enterprises and medical institutions shall cooperate with marketing authorization holders in carrying out pharmacovigilance activities.

Good Pharmacovigilance Practice is formulated by the drug regulatory department of the State Council.

Article 25If the marketing authorization holder of a pharmaceutical is an overseas enterprise, the legal person of the enterprise within China designated according to Article 38 of the Drug Administration Law shall possess corresponding quality management and risk control capabilities. It should establish relevant management departments and assign appropriate personnel; relevant information about the designated legal person of the enterprise within China shall be indicated in the drug instructions.

Article 26Marketing authorization holders of pharmaceuticals shall, in accordance with the regulations of the drug regulatory department of the State Council, provide accessible format versions of drug labels and instructions in audio, large print, braille, or electronic formats to facilitate medication use for people with disabilities and the elderly.

The content of the electronic version of the drug instructions must be consistent with the drug instructions approved by the State Council's drug regulatory authority and has the same effect as the paper version of the drug instructions; voice and Braille versions of drug labels and instructions are for reference.

Article 27The marketing authorization holder of a drug shall comprehensively evaluate and verify the impact of changes in the drug production process on the safety, efficacy, and quality control of the drug, and submit a change application or file a record and report according to the regulations of the drug regulatory department under the State Council.

The pharmaceutical supervision and administration department shall strengthen the supervision and management of changes in the process of drug production. If it is found that the evaluation and verification of the changes filed or reported by the drug marketing authorization holder are insufficient to prove that the changes are scientific, reasonable, and risk-controllable, or if it is found that the change management category selected by the drug marketing authorization holder is inappropriate, the department shall order the holder to make corrections, take corresponding risk control measures, and handle them according to law.

Article 28The marketing authorization holder of a drug shall continuously monitor the quality, efficacy, and adverse reactions of the registered drug.

The marketing authorization holder of a drug shall regularly conduct post-marketing evaluations of the registered drug, comprehensively analyze and assess the risks and benefits of the drug, and take measures such as revising the instructions, improving quality standards, refining production processes, suspending production and sales, implementing drug recalls, or applying for the cancellation of the drug registration certificate based on the results of the post-marketing evaluation. When necessary, the drug regulatory department under the State Council may order the marketing authorization holder to conduct a post-marketing evaluation or directly organize such an evaluation.

If the Marketing Authorization Holder (MAH) fails to continuously monitor the quality, efficacy, and adverse reactions of registered drugs as required, or does not conduct post-marketing evaluations as requested by the National Medical Products Administration (NMPA), the drug registration certificate will not be renewed upon expiration.

Article 29Chinese herbal pieces manufacturing enterprises and Chinese formula granules manufacturing enterprises fulfill the relevant obligations of a drug marketing authorization holder, implement whole-process management for the production and sale of Chinese herbal pieces and Chinese formula granules, establish a traceability system for Chinese herbal pieces and Chinese formula granules, and ensure their safety, efficacy, and traceability.


Chapter Four: Pharmaceutical Production


Article 30To engage in pharmaceutical production activities, an application must be submitted to the provincial government's drug regulatory authority where the entity is located, along with documentation proving compliance with the conditions stipulated in Article 42 of the Drug Administration Law. For vaccine production activities, additional documentation must be provided to demonstrate compliance with the provisions of Paragraph 3, Article 22 of the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law). The provincial government's drug regulatory authority shall organize a review and make a decision within 30 working days from the date of accepting the application. If the applicant meets the specified conditions, permission will be granted and a pharmaceutical production license will be issued; if the applicant does not meet the specified conditions, permission will be denied, and reasons will be provided in writing.

If a pharmaceutical manufacturing enterprise wants to change the licensed items on the drug production license, it must submit an application to the original issuing authority. The original issuing authority shall review the application and make a decision within 15 working days from the date of accepting the application.

The validity period of a drug production license is 5 years. Upon expiration, if continued production of drugs is required, an application for the reissuance of the drug production license must be submitted.

Article 31If the marketing authorization holder of a pharmaceutical product produces the drug by itself, it shall obtain a drug production license.

If the Marketing Authorization Holder (MAH) of a pharmaceutical product entrusts the production of drugs, it shall entrust a qualified pharmaceutical manufacturing enterprise. The MAH shall fulfill responsibilities such as supplier auditing, change management during the drug production process, and drug market release, supervise the entrusted manufacturing enterprise, and ensure that the entire drug production process continuously complies with legal requirements. The entrusted manufacturing enterprise shall organize production in accordance with Good Manufacturing Practice (GMP) for pharmaceuticals and shall not subcontract the production again.

Blood products, anesthetic drugs, psychotropic drugs, medically toxic drugs, drug-type precursor chemicals, and drugs containing anesthetic drugs, psychotropic drugs, or drug-type precursor chemical ingredients shall not be produced under commission; however, exceptions may apply as otherwise stipulated by the drug regulatory authority of the State Council.

Article 32If a marketing authorization holder of a pharmaceutical product indeed has the need, they may entrust the segmented production of the following pharmaceuticals to a qualified pharmaceutical manufacturing enterprise:

(1) Innovative drugs with special requirements for production processes and facilities;

(2) Drugs urgently needed for clinical use proposed by relevant departments of the State Council, drugs urgently needed to respond to public health emergencies, or drugs required for reserves;

(III) Other medicines stipulated by the drug regulatory department of the State Council.

If the marketing authorization holder of a pharmaceutical product entrusts the segmented production of the drug, they must establish a unified quality assurance system that covers the entire drug production process and all production sites to ensure that the entire drug production process continuously complies with legal requirements.

Article 33In any of the following circumstances, if it exceeds the production capacity of the vaccine marketing authorization holder, the vaccine marketing authorization holder may, upon approval by the drug regulatory department of the State Council, entrust a qualified vaccine manufacturer to produce or segmentally produce the vaccine:

(1) Production of multivalent vaccines;

(2) The relevant departments of the State Council propose urgent needs for disease prevention and control or reserve requirements;

(III) Other circumstances stipulated by the drug supervision and administration department of the State Council.

Article 34The production of vaccines, blood products, and other biological products shall truthfully record all data formed during the production and inspection processes using information-based methods as required by regulations.

Article 35Pharmaceuticals marketed in China but produced overseas must comply with the relevant requirements of the Drug Administration Law, these regulations, and other applicable laws, regulations, rules, standards, and norms. For overseas-produced drugs that are repackaged domestically, after the drug marketing authorization holder registers with the State Council's drug regulatory authority, the pharmaceutical manufacturing enterprises conducting the repackaging may sell their repackaged drugs to drug distribution companies or medical institutions.

Article 36The following drugs produced before obtaining the drug approval certificate can be marketed for sale after obtaining the drug approval certificate if they meet the drug marketing release requirements:

(1) Commercial-scale batch products that have passed the compliance inspection of the corresponding Good Manufacturing Practice (GMP) for pharmaceuticals;

(II) For new drugs, medicines for rare disease treatment, shortage drugs, and other clinically urgently needed drugs, the commercial-scale batches produced after passing the corresponding Good Manufacturing Practice (GMP) compliance inspection.

Marketing authorization holders of pharmaceuticals shall strengthen risk management for drugs marketed in accordance with the preceding paragraph.

Article 37The state encourages the standardized cultivation and breeding of Chinese medicinal materials and the use of authentic Chinese medicinal materials. Provincial governments formulate relevant plans based on local realities, encourage the implementation of Good Agricultural Practices (GAP) for Chinese medicinal materials, and promote the standardized cultivation and breeding of Chinese medicinal materials.

Based on the characteristics of Chinese medicinal materials, origin processing can be carried out. The provincial government's drug regulatory department should formulate guiding principles for the origin processing of Chinese medicinal materials according to the Good Agricultural Practice (GAP) for Chinese medicinal materials, combined with the local distribution of Chinese medicinal resources, traditional planting and breeding history, and the properties of authentic Chinese medicinal materials.

Article 38The Chinese medicinal materials used in the production of drugs shall comply with the national drug standards or drug registration standards. In the absence of national drug standards or drug registration standards, they shall comply with the regional folk customary medicinal material standards formulated by the provincial government's drug regulatory authorities.

First-time imports of Chinese medicinal materials shall be approved by the State Council's drug regulatory department. The State Council's drug regulatory department shall review and make a decision within 20 working days from the date of accepting the application.

Article 39Manufacturers of Chinese herbal slices must process the slices themselves and are not allowed to outsource the processing.

Processed Chinese herbal pieces should be prepared according to national drug standards; if there are no provisions in the national drug standards, they should be prepared according to the processing specifications formulated by the provincial government's drug regulatory authorities.

Chinese Herbal Pieces Processed According to the Processing Standards Formulated by the Provincial Drug Supervision and Administration Departments Can Be Sold and Used Across Provincial Administrative Regions. Among them, for Chinese herbal pieces with regional differences in processing methods and medication characteristics that are prone to cause confusion in clinical medication when sold across provincial administrative regions, the manufacturers of Chinese herbal pieces shall indicate clinical medication warning information on the labels of the Chinese herbal pieces and register with the drug supervision and administration departments of the purchasing and using provinces; medical institutions should strengthen procurement management and rational drug use monitoring to prevent confusion in clinical medication. Specific measures shall be formulated by the State Drug Supervision and Administration Department.

The labels of Chinese herbal decoction pieces should indicate product attributes, name, specifications, origin of Chinese medicinal materials, production enterprise, batch number, production date, packaging quantity, shelf life, implementation standards, storage conditions, etc.; for Chinese herbal decoction pieces under approval management, the drug approval number should also be indicated.

Article 40Manufacturers of Chinese medicine formula granules shall register the varieties of Chinese medicine formula granules they produce with the drug supervision and administration department of the provincial people's government where they are located.

Manufacturers of Chinese medicine formula granules should process Chinese medicinal slices for the production of Chinese medicine formula granules on their own and produce the granules themselves. They are not allowed to use purchased Chinese medicinal slices for the production of Chinese medicine formula granules, nor are they allowed to outsource the production of Chinese medicine formula granules.

Traditional Chinese medicine formula granules should be produced in accordance with national drug standards; if there are no national drug standards, they should be produced according to the standards for traditional Chinese medicine formula granules formulated by the provincial government's drug regulatory authorities.

Chinese Herbal Formula Granules produced in accordance with the standards formulated by the provincial government's drug regulatory authorities can be sold and used across provincial administrative regions; when Chinese Herbal Formula Granules are sold across provincial administrative regions, the生产企业应当向购进、使用地省级人民政府药品监督管理部门备案。

The label of Chinese medicine formula granules should indicate the product name, specifications, manufacturing enterprise, batch number, production date, shelf life, applicable standards, storage conditions, registration number, etc.

Pharmaceutical trading enterprises shall not operate Chinese medicine formula granules.

Article 41Engaged in the production activities of excipients, packaging materials and containers that directly contact pharmaceuticals, it is necessary to comply with the relevant provisions of Good Manufacturing Practice (GMP) for pharmaceuticals, establish and improve the production quality management system to ensure that the entire production process continuously meets statutory requirements.

Prohibit the use of excipients, packaging materials, and containers that have been eliminated by the state for direct contact with drugs in drug production.


Chapter Five: Pharmaceutical Operations


Article 42To engage in the operation of pharmaceuticals, an application must be submitted to the drug regulatory department of the local people's government at or above the county level, along with materials proving compliance with the conditions stipulated in Article 52 of the Drug Administration Law. The drug regulatory department of the local people's government at or above the county level shall organize a review and make a decision within 20 working days from the date of accepting the application. If the conditions stipulated are met, permission will be granted and a pharmaceutical operation license will be issued; if the conditions stipulated are not met, permission will be denied, and reasons will be provided in writing.

Pharmaceutical distribution enterprises that need to change the licensed items on their Pharmaceutical Distribution License must submit an application to the original issuing authority. The original issuing authority shall review the application and make a decision within 15 working days from the date of accepting the application.

The validity period of the Drug Operation Permit is 5 years. Upon expiration, those who wish to continue operating drugs must apply for the reissuance of the Drug Operation Permit.

Article 43Pharmaceutical trading enterprises should be equipped with pharmacists or other pharmaceutical technical personnel who have been qualified in accordance with the law and are commensurate with their business scope and scale; however, retail pharmaceutical enterprises that only sell Class B over-the-counter drugs can be equipped with pharmaceutical technical personnel in accordance with the regulations of the drug regulatory department of the State Council.

Retail pharmaceutical enterprises should sell prescription drugs based on prescriptions.

Article 44Marketing authorization holders, pharmaceutical manufacturers, and pharmaceutical distributors must take effective measures to ensure the quality of drugs during storage and transportation based on the drug's packaging, quality characteristics, temperature control requirements, etc. If marketing authorization holders, pharmaceutical manufacturers, or pharmaceutical distributors outsource the storage and transportation of drugs, they should select contractors with corresponding capabilities and supervise them. Contractors should strengthen the management of drug storage and transportation processes and take effective measures to ensure drug quality.

Retail pharmaceutical enterprises should deliver medicines to patients with independent packaging and prominent labeling.

Article 45Third-party platforms providing online drug transaction services shall establish and improve the quality management system for online drug sales, set up corresponding management departments, employ pharmaceutical technicians and other relevant professionals, and formulate and implement systems for drug quality management and delivery management. Third-party platforms providing online drug transaction services shall review the qualifications of drug marketing authorization holders and drug operating enterprises applying to operate on the platform, inspect the drug information displayed on the platform, and manage drug operating activities occurring on the platform. Third-party platforms providing online drug transaction services shall preserve records of reviews, inspections, and drug information displayed on the platform as required.

Third-party platform providers for online drug transactions, drug marketing authorization holders, and drug operating enterprises that provide services such as information display and link redirection for other third-party platform providers, drug marketing authorization holders, and drug operating enterprises to sell drugs online must comply with the regulations of the State Council's drug supervision and administration department.

Article 46Vaccines, blood products, anesthetic drugs, psychotropic drugs, medically toxic drugs, radioactive drugs, drug-type precursors and other drugs subject to special management by the state shall not be sold online; other drugs with higher medication risks shall not be retailed online. The specific list shall be formulated by the drug regulatory department of the State Council.

Article 47For applications submitted by medical institutions to import small quantities of drugs due to urgent clinical needs, the drug regulatory department of the State Council shall seek the opinion of the health authority under the State Council, conduct a timely review, and make a decision. Where the State Council authorizes provincial governments to implement approval, the authorized provincial governments should formulate specific approval methods based on local conditions.

Article 48Individuals carrying or mailing a small amount of medicine into the country should be limited to a reasonable and personal-use quantity, and comply with the national regulations on the management of personal items entering the country.


Chapter Six: Pharmaceutical Affairs Management in Medical Institutions


Article 49Medical institutions shall formulate and implement management systems for drug procurement inspection, storage, and use, and establish a corresponding management department or designate personnel responsible for drug quality management.

Article 50Medical institutions should strengthen the management of prescription issuance, review, and dispensing to improve physicians' rational drug use.

Article 51Physicians shall not prescribe medications specified in Article 46 of these Regulations during online medical consultations.

Article 52Medical institutions should provide patients with prescriptions that comply with the regulations of the health authority under the State Council, and patients can choose to purchase medicines from retail pharmaceutical enterprises based on these prescriptions.

Encourage the use of information technology to achieve prescription flow between medical institutions and pharmaceutical retail enterprises.

Article 53For drugs undergoing clinical trials that are intended to treat serious life-threatening diseases with no currently effective treatment options, if medical observation suggests potential benefits and ethical principles are met, they may be used on other patients with the same condition who cannot participate in the clinical trial within the institution conducting the trial, provided that the ethics committee has reviewed and approved, and the patient or their guardian has signed an informed consent form.

Article 54Medical institutions that prepare formulations should submit an application to the provincial government's drug regulatory department in their location, providing documentation proving that they meet the conditions stipulated in the first paragraph of Article 75 of the Drug Administration Law. The provincial government's drug regulatory department shall organize a review and make a decision within 30 working days from the date of accepting the application. If the conditions stipulated are met, permission will be granted, and a medical institution preparation license will be issued; if the conditions are not met, permission will be denied, and reasons will be provided in writing.

If a medical institution changes the licensed items of its Medical Institution Preparation License, it shall submit an application to the original issuing department. The original issuing department shall review the application and make a decision within 15 working days from the date of accepting the application.

The validity period of a Medical Institution Preparation License is 5 years. Upon expiration, if continued preparation of formulations is required, an application for the reissuance of the Medical Institution Preparation License must be made.

Article 55Medical institutions shall submit the data, materials, and samples of the intended preparation to the drug regulatory department of the provincial people's government where they are located. After obtaining the registration certificate for medical institution preparations through review and approval, they may proceed with the preparation; however, for traditional Chinese medicine preparations made using only traditional processes, medical institutions can proceed with the preparation after filing with the drug regulatory department of the provincial people's government where they are located.

When the provincial people's government drug supervision and administration department approves the registration application for medical institution preparations, it simultaneously verifies the quality standards, preparation process, labels, and instructions for the preparations.

The validity period of the medical institution preparation registration certificate is 3 years. If it is necessary to continue the preparation after the expiration, re-registration should be applied for.

Article 56For pediatric drugs that are clinically necessary but not available on the market or lack formulations and specifications suitable for children, the health authority under the State Council, in conjunction with the drug regulatory authority under the State Council, shall include them in the list of commonly used pediatric medical institution preparations. This supports medical institutions in preparing and using these drugs to meet the clinical medication needs of pediatric patients.

Article 57The following medicines shall not be used as medical institution preparations:

(1) Chemical drugs containing active ingredients not yet used in registered drugs;

(II) Chemical drugs with active ingredients of registered medicines used for new indications;

(3) Compound preparations composed of traditional Chinese medicine and chemical drugs;

(IV) Traditional Chinese Medicine Injection;

(5) Medical toxic drugs;

(6) Biological products other than allergens;

(7) Other medicines stipulated by the drug regulatory department of the State Council.

Article 58Medical institutions that prepare formulations should comply with the Good Preparation Practice for Medical Institution Formulations, establish and improve the quality management system for formulation preparation, and ensure that the entire process of formulation preparation continuously meets statutory requirements. The Good Preparation Practice for Medical Institution Formulations is formulated by the drug regulatory department of the State Council.

The legal representative and principal person in charge of a medical institution are fully responsible for the preparation activities of the institution's formulations.

Article 59Medical institution preparations can only be used in the medical institution with a doctor's prescription, and shall not be sold or indirectly sold on the market, nor shall advertisements for medical institution preparations be published.

In the event of a disaster, epidemic, or other emergencies, or when there is an urgent clinical need and no supply available on the market, the preparation of medical institutions can be adjusted for use among designated medical institutions within a specified period upon approval by the drug regulatory department of the provincial people's government. However, the adjustment of special medical institution preparations specified by the State Council’s drug regulatory department, as well as the adjustment across provincial administrative regions, must be approved by the State Council’s drug regulatory department. The drug regulatory departments of the people's governments at or above the provincial level shall review and make a decision within 5 working days from the date of accepting the application.

Article 60Medical institutions that discover suspected adverse drug reactions shall report them to the drug regulatory department and the health authority in a timely manner according to regulations.

Upon discovering suspected clustered adverse drug reaction events, medical institutions should promptly provide treatment to patients, take measures to control risks, and report the incidents to the drug regulatory authorities and health authorities in a timely manner as required. After receiving the reports, the drug regulatory authorities and health authorities should promptly investigate and handle the situation.

Article 61Medical institutions that discover quality issues with purchased or used drugs should immediately take measures to control the risks, promptly notify the supplier and the drug marketing authorization holder, and report to the drug supervision and administration department of the local county-level people's government.

Marketing authorization holders and supply units of pharmaceuticals should provide or publish email addresses, phone numbers, fax numbers, etc., to facilitate medical institutions in informing relevant information.

Article 62The drug supervision and administration department and the health and health authority supervise and manage the drug quality and drug use behavior in the drug use环节 according to their respective responsibilities.


Chapter Seven: Supervision and Management


Article 63The drug supervision and administration department may take the following measures to implement inspections:

(1) Enter the premises of drug research, production, operation, and use activities, as well as places providing related products or services for drug research, production, operation, and use, to conduct on-site inspections and sample collection;

(2) Review and copy relevant documents, records, invoices, vouchers, electronic data, and other materials; seal or seize materials that may be transferred, concealed, or destroyed;

(III) Seize or detain drugs and related raw materials, excipients, and packaging materials and containers that come into direct contact with drugs, which are evidenced to potentially harm human health;

(IV) Seize or detain tools, facilities, equipment, and premises for which there is evidence that they may be used for illegal activities.

When the drug supervision and administration department conducts inspections, there must be no fewer than two law enforcement officers, and they should present their law enforcement credentials. Relevant units and individuals should cooperate with the inspection and must not refuse or obstruct.

Article 64The drug regulatory department of the State Council shall formulate unified drug traceability standards and specifications. Marketing authorization holders and drug manufacturers shall assign traceability identifiers on drug packaging as required. Marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall provide traceability information as required to ensure drug traceability.

Article 65The State Council's drug regulatory department establishes national drug professional technical institutions according to procedure. Provincial government drug regulatory departments may establish local drug professional technical institutions according to procedure, based on the development of the local pharmaceuticals industry and the needs of regulatory work. National drug professional technical institutions should strengthen technical guidance for local drug professional technical institutions.

Drug regulatory departments of people's governments at or above the provincial level may designate qualified institutions to undertake relevant professional and technical work based on the needs of drug supervision and management.

Article 66The random inspection of drug quality should follow the principles of science, standardization, and impartiality.

The pharmaceuticals supervision and administration department shall formulate and implement a drug quality random inspection plan based on the needs of pharmaceuticals supervision and administration work.

In the random inspection of drug quality, drug sampling shall be carried out by two or more samplers in accordance with the regulations of the drug supervision and administration department under the State Council. The sampled entity shall cooperate with the samplers for sampling. If the sampled entity refuses to cooperate without proper reasons, the drug supervision and administration department may order the sampled entity to suspend the sale and use of the sampled drugs.

According to the needs of drug supervision and management, the drug supervision and administration department can conduct random inspections on excipients, packaging materials and containers that come into direct contact with drugs.

Article 67If a party has any objection to the test results of a pharmaceutical inspection agency, they may apply for a retest within 7 days from the date of receiving the pharmaceutical test results.

If applying for a retest, the retesting fees must be prepaid to the retesting institution according to regulations. If the retesting conclusion differs from the original testing conclusion, the retesting fees will be borne by the original pharmaceutical testing institution.

If the national drug standards stipulate that certain test items are not subject to reinspection, or if there are other circumstances specified by the drug regulatory department of the State Council that do not allow for reinspection, then reinspection shall not be carried out.

Article 68The results of random inspection and testing of drug quality announced by the drug regulatory departments of the people's governments at or above the provincial level shall include the name of the inspected drug, sample source, the designated drug marketing authorization holder and manufacturer or designated medical institution, product batch number, specifications, testing agency, testing basis, testing conclusion, non-conforming items, and other contents. If the announcement of the random inspection and testing results of drug quality is inappropriate, the issuing department shall make corrections within the scope of the original announcement within 5 working days from the date of confirming the inappropriateness.

Article 69For drugs that may be adulterated or counterfeit, if they cannot be tested according to the inspection items and methods specified in the national drug standards or drug registration standards, drug inspection institutions may use supplementary inspection items and methods approved by the drug regulatory department of the State Council for testing. The test results obtained using supplementary inspection items and methods can be used as the basis for determining drug quality.

Article 70Where the drug regulatory department takes risk control measures such as suspending production, sales, use, or import in accordance with the third paragraph of Article 99 of the Drug Administration Law, the drug marketing authorization holder, drug manufacturing enterprise, drug distribution enterprise, and medical institutions must carry out rectification to eliminate potential safety hazards. If the drug regulatory department evaluates and confirms compliance with relevant requirements, the implemented risk control measures should be lifted.

During the period when the drug regulatory departments of the people's governments at or above the provincial level take the risk control measures stipulated in the preceding paragraph, no advertisements for the relevant drugs shall be published; if they have been published, they shall be stopped immediately.

Article 71The following circumstances fall under the category of counterfeit drugs as stipulated in Article 98, Paragraph 2, Item 2 of the Drug Administration Law:

(1) Substances or components that do not possess disease prevention, treatment, or diagnostic functions, or substances with unclear compositions, which are claimed on labels or instructions to have such functions and are passed off as drugs;

(2) Using the name or approval number of other drugs, and indicating on the label or instruction manual indications or functions that the drug does not possess;

(III) The ingredients of the drug do not match the ingredients stated on its label or in the instructions;

(4) Labeling with false drug approval numbers or drug marketing authorization holders;

(5) Other situations where non-drugs are passed off as drugs or one kind of drug is passed off as another kind of drug.

Article 72According to Article 98, Paragraph 2, Item 4 of the Drug Administration Law, the identification of counterfeit drugs, as well as the identification of substandard drugs according to Article 98, Paragraph 3, Items 3 to 5 of the Drug Administration Law, does not require drug testing. The identification of counterfeit or substandard drugs according to other provisions of Paragraph 2 and Paragraph 3 of Article 98 of the Drug Administration Law shall undergo drug testing; however, if evidence such as records of the procurement and use of raw materials and excipients can sufficiently prove that the drugs are counterfeit or substandard, drug testing may be omitted.

Article 73Units where drug safety incidents occur should immediately take measures to prevent the harm from expanding, and promptly report the incident to the drug supervision and administration department of the county-level people's government at the location where the incident occurred.

Upon discovering a pharmaceutical safety incident, medical institutions should immediately report the incident to the drug supervision and administration department of the county-level people's government at the location where the incident occurred, as well as to the health and wellness authority.

After receiving the report, the drug regulatory department shall immediately report to the people's government at the same level and the drug regulatory department of the higher-level people's government according to the regulations.

People's governments at or above the county level shall, in accordance with the emergency response plans for drug safety incidents, organize and carry out response efforts.

Article 74The state strengthens drug reserves and implements a two-level reserve system at the central and local levels. The specific measures shall be formulated by the competent department of industry and information technology under the State Council in conjunction with relevant departments under the State Council.

Article 75The health authority under the State Council, in conjunction with relevant departments of the State Council, formulates national drug policies and the national essential medicines system, and improves the management mechanism for the national essential medicines list.

Article 76Market supervision and management departments strengthen anti-monopoly and anti-unfair competition supervision in drug production and operation, and investigate and deal with illegal acts of monopoly and unfair competition according to law, so as to maintain a fair competitive order.

Article 77If departments such as drug supervision and management discover problem leads suggesting that public officials are suspected of duty-related violations or crimes during supervision and management, they should promptly transfer the case to the supervisory authority.

Article 78Charges may be levied for drug registration, drug registration inspection, and mandatory inspection. Specific charge items and standards are formulated by the financial department and the development and reform department of the State Council in accordance with relevant national regulations.


Chapter VIII Legal Liability


Article 79In any of the following circumstances, the drug regulatory department of the local people's government at or above the county level shall order a time limit for correction, confiscate the drugs produced or sold illegally and the illegal proceeds, and impose a fine of 10 to 20 times the value of the drugs produced or sold illegally. If the value of the drugs produced or wholesaled illegally is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of the drugs retailed illegally is less than 10,000 yuan, it shall be calculated as 10,000 yuan. In serious cases, the department shall also order the suspension of production and business operations for rectification until the original licensing authority revokes the drug production license or drug operation license:

(1) The marketing authorization holder of a drug violates Article 36 of these Regulations by selling commercially scaled batches of products manufactured before obtaining the drug approval certification;

(2) Chinese herbal pieces production enterprises entrust the processing of Chinese herbal pieces or Chinese formula granules production enterprises entrust the production of Chinese formula granules;

(III) Pharmaceutical trading enterprises operating Chinese medicine formula granules and medical institution preparations;

(IV) Violation of Article 46 of this Regulation by selling drugs online.

Article 80In any of the following circumstances, the provincial people's government drug supervision and administration department shall order a time limit for correction and issue a warning; if the violation is not corrected within the time limit, a fine of more than 100,000 yuan but less than 500,000 yuan shall be imposed:

(1) Enterprises producing Chinese herbal pieces and Chinese formula granules fail to register according to the provisions of the third paragraph of Article 39 and the fourth paragraph of Article 40 of this Regulation when selling Chinese herbal pieces and Chinese formula granules across provincial administrative regions.

(II) The production enterprise of Chinese medicine formula granules fails to file for record in accordance with the provisions of the first paragraph of Article 40 of this Regulation.

Article 81Medical institutions that use preparations made by other medical institutions without approval shall be punished in accordance with Articles 129 and 139 of the Drug Administration Law.

If a medical institution falls under any of the following circumstances, it shall be ordered by the drug supervision and administration department of the local people's government at or above the county level to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined between 10,000 yuan and 100,000 yuan:

(1) Failure to formulate and implement management systems for drug procurement inspection, storage, and use in accordance with regulations;

(2) Discovering that the purchased or used drugs have quality issues, but failing to take measures or report as required.

Article 82For applications such as the qualification of non-clinical safety evaluation research institutions for drugs, drug clinical trial permits, drug production permits, drug business permits, medical institution preparation permits, and drug registration permits, if false certificates, data, materials, samples, or other deceptive means are provided, the drug regulatory departments of the people's governments at or above the county level will not accept or grant the permit. The corresponding application will not be accepted for 10 years, and a fine of more than 500,000 yuan but less than 5 million yuan will be imposed. In serious cases, the legal representative, principal person in charge, directly responsible managerial personnel, and other responsible persons will also be fined between 20,000 yuan and 200,000 yuan and will be prohibited from engaging in drug production and business activities for 10 years.

If the false certificates, data, materials, or samples submitted by the applicant are forged or fabricated by a non-clinical safety evaluation research institution, a clinical trial institution, or other institutions entrusted to carry out drug research and development-related activities, the drug supervision and administration department of the people's government at or above the provincial level shall impose penalties on the non-clinical safety evaluation research institution, clinical trial institution, or other institutions entrusted to carry out drug research and development-related activities in accordance with Article 126 of the Drug Administration Law.

Article 83If a registered drug clinical trial institution does not meet the registration requirements, the drug regulatory department of the people's government at or above the provincial level shall order it to make corrections within a specified time limit; if it still does not meet the registration requirements after the deadline, the relevant drug clinical trial professional registration or drug clinical trial institution registration will be canceled, and it will be prohibited from conducting relevant professional drug clinical trials for 1 year or prohibited from conducting drug clinical trials for 1 year.

If false proof is provided when filing for the record of a drug clinical trial institution, the drug regulatory department of the people's government at or above the provincial level shall cancel the relevant drug clinical trial professional record or the drug clinical trial institution record, prohibit it from conducting relevant professional drug clinical trials for 3 years or prohibit it from conducting drug clinical trials for 3 years, confiscate illegal gains, and impose a fine of more than 100,000 yuan but less than 500,000 yuan. The relevant clinical trial data shall not be used for applying for drug registration.

Article 84If a third-party platform provider for online drug transactions fails to establish and improve the quality management system for online drug sales in accordance with regulations, the provincial government's drug regulatory authority shall order it to make corrections within a specified time limit and issue a warning; if the corrections are not made by the deadline, a fine of more than 100,000 yuan but less than 500,000 yuan shall be imposed; in serious cases, a fine of more than 500,000 yuan but less than 2 million yuan shall be imposed.

Third-party platform providers for online drug transactions, drug marketing authorization holders, and drug operating enterprises that provide information display, link redirection, or other services for other third-party platform providers, drug marketing authorization holders, or drug operating enterprises to sell drugs online in violation of the regulations set by the State Council’s drug regulatory authority shall be ordered by the provincial government's drug regulatory department to rectify within a specified time limit and receive a warning. If they fail to correct the violation within the stipulated time, their illegal gains will be confiscated, and they will be fined between 100,000 and 500,000 yuan. In serious cases, their illegal gains will be confiscated, and they will be fined between 500,000 and 2 million yuan.

Article 85Failure to comply with the risk control measures lawfully taken by the drug regulatory department, such as suspension of production, sales, use, or import, will result in a fine of 5 to 10 times the value of the illegally produced, sold, used, or imported drugs imposed by the drug regulatory department of the people's government at or above the county level. If the value of the goods is less than 10,000 yuan, it will be calculated as 10,000 yuan. In serious cases, an order to suspend production and business operations for rectification will also be issued, up to the revocation of the drug approval documents, drug production license, drug business license, or medical institution preparation license by the original issuing authority. Additionally, fines ranging from 20,000 to 200,000 yuan will be imposed on the legal representative, principal responsible person, directly responsible manager, and other responsible persons.

In violation of the Drug Administration Law, Vaccine Administration Law, and the provisions of this Regulation, those who refuse or obstruct inspections shall be ordered by the drug regulatory authorities of the people's governments at or above the county level to correct within a specified time limit and be fined no more than 50,000 yuan; in serious cases, they shall be ordered to suspend production and business operations for rectification.

Article 86If pharmaceutical distribution enterprises and medical institutions have fulfilled the obligations of inspection and acceptance of goods as stipulated in the Drug Administration Law, the Vaccine Administration Law, and this Regulation, and there is sufficient evidence to prove that they did not know that the drugs they sold or used were counterfeit or substandard drugs, they will be exempt from punishment. However, the counterfeit or substandard drugs they sold or used shall be confiscated; if they cause personal injury, property damage, or other damages, they shall bear compensation liability according to law.

Article 87If the drug regulatory department and its staff violate the provisions of this Regulation by disclosing undisclosed test data or other data of the drug marketing authorization holder, causing losses to the drug marketing authorization holder, the drug regulatory department shall bear compensation liability according to law. After compensating for the losses, the drug regulatory department shall order the staff who intentionally or grossly negligently caused the losses to bear part or all of the compensation costs, and impose disciplinary sanctions on the responsible leading personnel and directly responsible personnel according to law.


Chapter Nine: Supplementary Provisions


Article 88The time required for drug registration review, as well as the technical review involved in the qualification application for non-clinical safety evaluation research institutions, drug production license application, drug business license application, and medical institution preparation license application, is not included in the timeframe for administrative licensing implemented by the drug regulatory authorities.

Article Eighty-NineThis regulation shall come into effect on May 15, 2026.