Beijing's Regulatory Reforms Accelerate Drug Approvals to Record-Breaking Speeds: 18-Day Clinical Approval and Minute-Level Customs Clearance

In an era marked by a surging wave of innovation in biomedicine, accelerating the translation of cutting-edge technologies from the laboratory to clinical practice for the benefit of patients has become a pivotal issue for urban industrial development.

On October 16, Beijing held a press conference on the comprehensive deepening of regulatory reforms for drugs and medical devices to promote the high-quality development of the pharmaceutical industry. VCBeat learned from the event that Beijing is strategically positioning itself in frontier fields such as “AI + pharmaceuticals and healthcare,” cell and gene therapy, brain-computer interfaces, surgical robots, and the innovative translation of traditional Chinese medicine, thereby accumulating new momentum for high-quality development.

In this reform, “speed” has become the most striking footnote.

Beijing has accelerated the market launch of innovative drugs and medical devices through a series of policies, including deepening the construction of a pilot zone for rare disease drug coverage and establishing green channels for the approval of clinically urgent imported drugs and medical devices; optimizing pilot programs for the review and approval of clinical trials for innovative drugs; reforming pilot programs to streamline the review and approval procedures for supplemental drug applications; and facilitating the import and commercial-scale sales of batch products from overseas-marketed drugs prior to their formal approval.

A series of figures demonstrate the “Beijing Speed”: Currently, 14 projects have been included in the pilot program for the review and approval of clinical trials for innovative drugs, with the fastest approval obtained within 18 working days and clinical trials initiated within one week. Commercial-scale batches of drugs already marketed overseas are permitted to be imported and sold prior to final approval. To date, 27 product specifications of commercial-scale batches have been imported through Beijing ports, with a customs clearance value of RMB 5.007 billion. The average review time for the initial registration of Class II medical devices has been reduced to 45 working days, representing a 63% increase in speed compared to the statutory timeframe (120 working days).

With the unveiling of the Beijing Review and Inspection Sub-Center for Drugs and Medical Devices under the National Medical Products Administration (NMPA) in the Jing-Jin-Ji region, the coordinated deployment of the city’s four major innovation service stations across the east, west, south, and north districts, and the continuous expansion of the “dual-channel” pharmacy network, Beijing is building a comprehensive support system spanning the entire chain from R&D and clinical trials to regulatory approval and payment.

In terms of policy integration, Beijing has successively issued the 2024 and 2025 editions of the Several Measures to Support the High-Quality Development of Innovative Medicines in Beijing (hereinafter referred to as the “Old and New 32 Articles”), covering six breakthrough policies including guaranteed access to rare disease drugs, segmented production of biological products, and expedited review of medical devices, thereby establishing a nationally leading system for institutional innovation.

During the clinical trial phase, the Beijing Municipal Medical Products Administration pioneered a pilot program for the review and approval of innovative drug clinical trials. During the pilot period, 14 projects were included, with an average approval time of only 24.6 working days and a shortest time of just 18 working days. The average time from approval to initiation was 5 weeks, with the shortest being only 1 week, representing a significant acceleration compared to the previous 6-month initiation cycle. This reform has greatly enhanced R&D efficiency for enterprises and accelerated the market launch of new drugs.

To ensure the quality and safety of clinical trials, the Beijing Municipal Medical Products Administration adheres to the “four strictest” regulatory requirements, strengthens whole-process oversight of pilot projects, and urges applicants and institutions to implement risk management plans, thereby safeguarding the rights and interests of subjects and ensuring data authenticity.

Notably, all five pilot projects submitted by Peking University Cancer Hospital were approved. According to Song Yuqin, Vice President of Peking University Cancer Hospital, the average review time by the Center for Drug Evaluation (CDE) of the National Medical Products Administration was only 22.4 working days, with the shortest review cycle being just 18 working days, significantly reducing the waiting time for innovative drugs to enter clinical trials. From the approval of the Investigational New Drug (IND) application notification to the signing of the first subject’s informed consent form, the average time taken was 7.9 weeks, with the fastest case taking only 3.9 weeks, thereby securing valuable time to ensure that innovative drugs benefit patients more rapidly.

At the customs clearance stage for imported drugs, Beijing Customs has innovatively launched “Six Models,” including “Intelligent Approval” for special items and “Integrated Three-Chain” smart quarantine. These measures enable “instant approval” for low-risk items, triple quarantine efficiency, and reduce processing time from 3–5 days to the “minute level.”

The Beijing Institute for Drug Control has implemented an “immediate testing upon receipt” protocol for drugs in urgent clinical need. In 2025, it completed expedited testing for 16 imported drug products, with several setting new records for the fastest turnaround times in the respective companies’ histories.

Hu Qin, Deputy Director of the Beijing Institute for Drug Control, stated that port-of-entry testing for erdafitinib tablets, a new targeted drug for treating specific types of bladder cancer, and lanzetinib mesylate tablets, a new targeted drug used in combination therapy for lung cancer, took 15 days and 9 days, respectively. Port-of-entry testing for asiminib tablets, a new targeted drug for treating acute lymphoblastic leukemia, was completed in 11 days, with only 39 days elapsing between the drug’s approval and its clinical use by patients.

Since 2024, policies such as “allowing the import of commercial batches prior to approval” and “immediate receipt and inspection of clinically urgent drugs and medical devices” have facilitated the market entry of 67 new imported drug varieties in Beijing, with a total cargo value of $790 million, thereby enabling the simultaneous launch of global new drugs in the Chinese market.

By launching a pilot program for segmented manufacturing of biological products, Beijing has facilitated the simultaneous global submission and market approval of innovative drugs. Janssen Pharmaceuticals’ nicalizumab injection has become the first imported biological product in China to receive approval for a pilot program involving domestic segmented manufacturing of drug substance. Additionally, two other products have already initiated their application processes.

Beijing leverages platform development as a strategic driver to systematically establish a full-chain support system spanning from basic research to industrial commercialization, thereby building a globally attractive ecosystem for pharmaceutical innovation.

In terms of basic research and clinical translation, Gong Weimi, Deputy Director of the Beijing Municipal Science & Technology Commission and the Administrative Committee of Zhongguancun Science Park, stated that to date, the annual funding scale of the Joint Fund for Medicine and Health under the Beijing Natural Science Foundation has reached RMB 588 million, with capital contributions from 29 enterprises and two public welfare foundations.

Meanwhile, Beijing has systematically laid out its presence in frontier fields such as AI-enabled pharmaceuticals, cell and gene therapy, brain-computer interfaces (BCI), surgical robots, and innovative traditional Chinese medicine, promoting the development of multiple Zhongguancun specialized industrial parks. Taking the first Zhongguancun specialized industrial park for brain science and BCI, launched in Changping District, as an example, it has gathered more than 20 innovative enterprises and established relevant service platforms, special policies, and a 300 million yuan incubation fund.

In terms of public service platforms, Beijing is accelerating efforts to address shortcomings in key areas such as large-animal clinical medical experiments, CDMO (Contract Development and Manufacturing Organization), and surgical robot training. Relying on the Tongzhou Campus of Anzhen Hospital, a 6,000-square-meter experimental animal platform has been established to support more than 60 innovative projects. The city supports the construction of new CDMO platforms for gene therapies, including CAR-T, LNP, and AAV. Additionally, it is building a surgical robot training center and establishing a leasing platform for high-end medical devices such as robots, thereby resolving the “last mile” challenge for the adoption of surgical robots in hospitals.

From clinical development to clinical application, platform empowerment is even more essential. Cao Wei, Director of the Beijing Municipal Medical Products Administration, acknowledged that an innovative drug must go through a series of stages from discovery to final market approval, including drug discovery, preclinical research, Investigational New Drug (IND) application, clinical studies, and New Drug Application (NDA), with uncertainties present at every step.

The Beijing-Tianjin-Hebei Branch of the Center for Drug Evaluation and Medical Device Evaluation under the National Medical Products Administration (NMPA), officially unveiled on September 21, 2025, operates in accordance with the principles of “early intervention, tailored strategies for each enterprise, full-process guidance, and integrated review and evaluation.” It directs more review resources toward priority innovative drugs and medical devices urgently needed in clinical practice, thereby accelerating the review and approval process across stages including clinical trials, registration submissions, and inspections and testing. VCBeat has learned that this branch serves Beijing, Tianjin, Hebei, and Shandong.

In addition, the Beijing Municipal Medical Products Administration (MPA) established China’s first national-level medical device innovation service station in Changping District, jointly built by the drug regulatory and science and technology departments. As a pioneering initiative, this provincial-level drug and medical device innovation service station now operates four sites across Yizhuang, Changping, Daxing, and Haidian districts, forming a coordinated “east–west–south–north” service network throughout the city. This layout further reduces the travel burden for enterprises and enhances their sense of gain. In 2025, the innovation service stations served more than 1,200 enterprise visits and resolved over 3,000 consultation inquiries.

The Beijing Institute for Medical Device Testing has established standard testing capabilities covering frontier technological fields of sustained industry interest, including medical robots, artificial intelligence, and biomedical materials. Cao Wei stated that the average testing duration for passive devices has been reduced to 60 working days, while that for active devices has been reduced to 90 working days. Its testing capability for ultra-large innovative radiotherapy equipment continues to lead the country, with the testing cycle shortened to four months.

The Beijing Municipal Healthcare Security Administration has systematically addressed challenges such as difficulties in hospital access, slow reimbursement processes, and limited payment options for innovative drugs and medical devices. This has been achieved through measures including optimizing online listing procedures, dynamically adjusting the reimbursement catalog, improving payment mechanisms, and promoting the “dual-channel” policy, thereby accelerating patient access to innovative healthcare solutions.

In terms of online listing and formulary management, Beijing has established a green channel for the online listing of innovative drugs, facilitating the rapid listing of 51 innovative drugs in 2025. The dynamic adjustment mechanism of the National Reimbursement Drug List (NRDL) has shortened the adjustment cycle from up to eight years to one year. Over the past eight years, a total of 835 new drugs have been added to the list, including 149 innovative drugs, with approximately 80% of innovative drugs being included in the national medical insurance coverage within two years of their market launch. Beijing has promptly implemented the national formulary updates, and the current Basic Medical Insurance Drug List comprises 3,159 drugs.

In the realm of innovative medical devices and technologies, Beijing has broken away from traditional pricing cycles by initiating pricing assessments immediately upon project approval for innovative technologies, while concurrently evaluating their inclusion in medical insurance coverage. Seventeen innovative technologies, including Tinavi’s surgical robots and Haijieya’s “Combo Knife,” have been included in the reimbursement list, thereby promoting clinical translation and empowering industrial development.

Regarding the implementation of "nationally negotiated drugs," Beijing has established a "dual-channel" supply mechanism, directly incorporating 570 nationally negotiated drugs into the formularies of designated medical institutions to ensure their full availability. Meanwhile, the impact of these drugs on relevant performance indicators of medical institutions is excluded from the global budget caps, with separate payment mechanisms implemented. In 2024, the basic medical insurance fund made separate payments totaling RMB 4.5 billion for nationally negotiated drugs. From January to July 2025, these drugs benefited 13.05 million patient visits, with total expenditures amounting to RMB 3.95 billion.

Which pharmacies should patients visit to purchase drugs included in the National Reimbursement Drug List (NRDL) negotiations? Given the limited storage capacity of hospital pharmacies, many patients have reported difficulties in accessing certain NRDL-negotiated drugs.

Han Bo, Director of the Pharmaceutical Services Division of the Beijing Municipal Healthcare Security Administration, stated that pilot work for “dual-channel” management would be carried out at selected tertiary-level designated medical institutions characterized by high outpatient volumes, advanced diagnostic and treatment capabilities, and significant clinical demand for drugs included in the National Reimbursement Drug List (NRDL) negotiations. In accordance with the selection criteria, one designated retail pharmacy would be accredited in the vicinity of each participating medical institution to supply these NRDL-negotiated drugs.

Regarding the development of "dual-channel" pharmacies, Beijing has designated 22 pharmacies near 110 tertiary hospitals to supply national negotiated drugs that are not yet available within these hospitals. For employees enrolled in the medical insurance scheme, the reimbursement rate for purchases at "dual-channel" pharmacies ranges from 80% to 85.5%, which is higher than that at medical institutions, and no deductible applies. From January to July 2025, a total of 308 types of national negotiated drugs were settled through dual-channel pharmacies, with the number of patient visits increasing by 293% year-on-year and total costs amounting to RMB 130 million, effectively alleviating patients' difficulties in accessing medications.

In the realm of commercial health insurance, "Beijing Puhui Health Insurance" has established a specialized drug list that is dynamically adjusted. It currently covers 121 drugs, including 65 overseas specialty drugs and 5 drugs for rare diseases, spanning more than 40 types of cancer. The Beijing Municipal Healthcare Security Administration encourages commercial insurance companies to develop products covering a broader range of innovative drugs and medical devices, promotes "one-stop" settlement between basic medical insurance and commercial insurance, and guides insurance capital to support innovation in the pharmaceutical industry through equity investments, funds, and other means.