Beijing's "32 Measures" Three-Year Iteration: 75% Acceleration in Drug Supplement Applications, Promoting the Launch of 29 Imported Drugs and Medical Devices

In the rapidly evolving biopharmaceutical industry, Beijing has introduced for three consecutive years the "32 Clauses," officially known as the Several Measures of Beijing Municipality to Support the High-Quality Development of Innovative Pharmaceuticals (hereinafter referred to as the "32 Clauses").

When a globally pioneering product enters the review channel, there are no similar products for reference and no ready-made path to follow. What distinctive support does Beijing provide for innovative pharmaceuticals and medical devices?

VCBeat learned from the Beijing Municipal Drug Administration (hereinafter referred to as "Beijing Drug Administration") that the "Innovative Pharmaceutical and Medical Device Project Management" service mechanism created by the Beijing Drug Administration, with its core principles of "early intervention, one product one policy, full-process guidance, and research-review coordination," has been continuously expanding and improving in quality since its launch in 2024.

Data shows that the first batch includes 200 innovative varieties, expanding to 324 by 2025, fully covering cutting-edge innovative fields such as cell and gene therapy, brain-computer interfaces, artificial intelligence medical devices, and surgical robots; by 2026, standards will be raised again with the goal of cumulatively including no fewer than 400 innovative varieties, providing enterprises with full-process exclusive service guarantees from research and development, testing, registration, to market entry, hospital adoption, and medical insurance integration.

The competition in pharmaceutical and device innovation ultimately boils down to a race against time.

For a Biotech company, every month shortened in the review cycle means relief of cash flow pressure, extension of the financing window, and consolidation of the first-mover advantage in going public.

Under the project-based management system, in 2025, Beijing was approved for 6 innovative drugs and 10 Class III innovative medical devices. The number of approved innovative drugs reached the highest annual record during the "14th Five-Year Plan" period, including China's first stem cell therapy drug, as well as several breakthrough innovative products such as the coronary artery interventional surgery control system; 18 Class II innovative medical devices were approved, marking a year-on-year increase of 50%.

As of now, Beijing has cumulatively approved 86 national innovative medical devices, 43 surgical robots, and 60 artificial intelligence medical devices, ranking first in China in all categories. Over the past three years, Beijing has promoted the approval of 29 imported drugs and medical devices, including 21 rare disease medicines, with the number of approvals ranking among the top in China.

Since 2026, Beijing has facilitated the approval and market launch of two innovative drugs—Huahui Anjian's Libivirumab Injection and Tian Guangshi's Otelixizumab β Injection—as well as four Class III innovative medical devices and four Class II innovative medical devices.

Bayer Imaging Diagnostics Vice President Sean Sullivan disclosed a set of comparative data at the communication meeting. The Bayer MEDRAD Mark 7 Arterion high-pressure contrast injection system was awarded a medical device registration certificate for products made in China by the Beijing Municipal Drug Administration on April 3, 2026.

Zhang Yadong, Director of the Drug Registration Department of the Beijing Municipal Drug Administration, stated that project-based management is a signature initiative of Beijing's drug regulatory service for pharmaceutical innovation. By mobilizing multi-party resources to build a full-chain, refined innovation service system, the aim is to reduce waiting times for innovative research and development, minimize concerns for enterprise development, and enable patients to benefit earlier.

The benefits of faster review are not limited to innovative drugs and medical devices. For pharmaceutical companies with generic drug businesses, the policy also offers positive implications. The new 32 measures propose exploring pre-approval services for generic drug marketing applications.

In this regard, Guo Xin, Chief Public Relations Officer of China Resources Double-Crane, clearly stated that the company is currently most focused on the implementation of pre-submission services for generic drug marketing applications. "Although China Resources Double-Crane has heavily invested in pharmaceutical innovation and R&D in recent years, generic drugs remain our core business. Once pre-submission services are implemented, it will significantly reduce the time cost and compliance costs associated with approval waiting."

Supplemental applications for pharmaceuticals have been included in Article 32 for three consecutive years. This year's updated Article 32 also proposes to optimize the review and approval process for supplemental applications of drugs produced overseas.

As of now, Beijing has provided pre-approval guidance for 26 overseas drug varieties from 16 domestic responsible entities, and completed three pilot pre-approval services for overseas products. All related varieties are among the first batch of overseas pilot varieties accepted by the National Medical Products Administration, accumulating valuable practical experience for the reform of supplementary applications for overseas-produced drugs in China.

At the same time, the Beijing Municipal Medical Products Administration provides full-chain services for major changes after the domestic drug marketing, including pre-guidance, on-site inspection, sampling inspection, and document filing.

Since the pilot program launched in November 2024, the reform achievements have continued to be prominent. To date, 53 pilot pre-services have been completed, of which 22 have been officially approved; the average time from acceptance to approval for drug supplemental applications is only 50 working days, compared to the original review period of 200 working days, achieving an overall acceleration of 75%, and meeting the anticipated reform goal of 60 working days.

It is worth noting that speeding up does not mean lowering standards. Relevant officials from the Beijing Municipal Medical Products Administration emphasized that, under the premise of adhering to the regulatory bottom line of "no reduction in procedures or standards," they aim to precisely address pain points and bottlenecks in the review and approval process, significantly improving the efficiency of supplementary application reviews for pharmaceuticals and refining the post-marketing change management mechanism for drugs. The core mechanism behind the efficiency improvement is "two-way collaboration," where regulatory authorities provide early guidance to help companies resolve compliance issues at the front end, thereby reducing back-and-forth corrections after formal submission.

The acceleration of the review process addresses the "certainty" issue, while true original innovation still faces the challenge of establishing review and approval standards. When a product is globally unprecedented in terms of indications, therapies, and surgical methods, the review standards themselves need to be built from scratch.

From completing type inspection in 2022 to gaining approval by March 2026, the i-NYS Implantable Ocular Muscle Neurostimulator developed by SuperVision Technology took five years. Wang Tianfang, CEO of SuperVision Technology, frankly stated: "For a globally first-of-its-kind product, the biggest challenge isn't waiting in line but rather not knowing where to start. With no similar products to refer to, all evaluation standards had to be established from scratch."

After the product was included in project-based management, the Beijing Municipal Medical Products Administration arranged for a dedicated person to handle the entire process, providing early guidance on key steps such as registration application, inspection, and verification. This approach precisely resolved compliance issues and significantly shortened the R&D and market launch cycle.

The experience of Huahui Anjian also reflects the service concept of the Beijing Municipal Drug Administration, which is oriented towards enterprise needs and focuses on innovation-driven development, providing strong support for enterprise growth.

Huahui Anjian's Libivirumab Injection was approved in January 2026, becoming the world's first antibody drug for viral hepatitis and China's first treatment for hepatitis D. Ye Bin, Chief Scientific Officer of Huahui Anjian, stated that every step from drug registration, production licensing to GMP quality control—including document preparation, application, processing, inspection, rectification, and more—has been handled through direct point-to-point coordination by relevant personnel.

Wu Di, General Manager of HuaKe Precision, has more specific feelings. Their neurosurgical robot product, due to its multidisciplinary nature and lack of similar products for reference, once faced difficulties in classification definition and clinical pathways. Project-based management helped the company identify the key directions for non-clinical research and clinical evaluation.

In the more cutting-edge field of brain-computer interfaces, standard issues are even more prominent. The New 32 Clauses explicitly propose to carry out research and development of core components such as high-throughput flexible deep electrodes and to develop 512-channel invasive products, accelerating clinical validation.

From technical validation to product approval, regulatory oversight is still essential.

It is reported that the Beijing Institute of Medical Device Testing, relying on the city's innovative pharmaceutical development support policies, has launched three core service initiatives: First, it provides pre-testing services for innovative medical devices, offering full-process cultivation guidance for innovative products to solve testing technical problems caused by the lack of standards, methods, and equipment, helping heavyweight innovative products like the "BeiNao No.1" brain-computer interface successfully pass inspections and enter the clinical trial stage; Second, it takes the lead in completing the expansion of new national standards for the safety of medical laboratory equipment, obtaining authorization for several important standards, continuously implementing immediate acceptance and testing for innovative products, and fully accelerating the market entry of corporate products; Third, it deepens international testing and certification cooperation, establishing in-depth collaborations with three internationally renowned organizations—Canada’s CSA, Germany’s TÜV Rheinland, and Norway’s DNV—to build an integrated service system for testing and certification, standard alignment, and market access, providing comprehensive technical support for local medical device companies' products to go global.

Moreover, the innovation chain from enterprises to hospitals is being打通. The new 32 measures explicitly state that medical institutions that directly lead clinical research and transformation of Class 1 innovative drugs and devices should be the first to use them in hospitals. Promote the use of surgical robots in hospitals. Conduct clinical effectiveness evaluations and health technology assessments of surgical robot applications. Incorporate the joint development of surgical robots, usage effectiveness, and the openness of robot full-scene situations into public hospital performance monitoring.

Relevant corporate executives stated that previously, purchasing equipment was a cost pressure for hospitals, but now it has become an added bonus for assessment. This has put clinical promotion on the fast track, significantly reducing the cost of communication with hospitals and enabling companies to focus more on enhancing the clinical value of innovative products.