Innovative Drug Registration in China: Expanding Policy Support in Beijing and Shenzhen

Innovative drugs seeking registration in China have received expanded policy support in Beijing and Shenzhen through new regulatory measures launched on April 7, 2024. These coordinated initiatives streamline the entry of innovative drugs (and medical devices) by reducing approval timelines, enhancing medical insurance mechanisms, and increasing financial support. For international manufacturers, the changes encourage access the Chinese market more efficiently and with policy support. Companies are given even more reason to more closely examine these 2 cities in China for product landing given the continuing policy encouragement and to take full advantage of these developments.

In June 2025, the National Medical Products Administration (NMPA) released a draft announcement summarizing the outcomes of a national pilot program aimed at optimizing the review and approval of clinical trial applications for innovative drugs. The initiative follows the State Council’s policy document (Guo Ban Fa [2024] No. 53), which calls for advancing pharmaceutical regulatory reform and promoting high-quality development in the drug industry.

Beijing's Support Measures for Innovative Drugs and Medical Devices

The Beijing Municipal Medical Security Bureau has issued the "Several Measures for Supporting the High-Quality Development of Innovative Medicines in Beijing (2025)," marking the second consecutive year that Beijing has introduced special policies to support the development of innovative medicines.

The 2025 version of the measures proposes several specific tasks, including further reducing the overall time for initiating clinical trial projects to within 20 weeks; compressing the review and approval time for innovative drug clinical trials from 60 working days to 30 working days and expanding the pilot varieties; directly incorporating national medical insurance negotiation drugs into the drug directories of medical institutions; deploying AI + pathology and AI + pharmaceuticals scenario model development; and establishing a 50 billion yuan scale medical and health industry fund.

Beijing will not include eligible innovative drugs in the DRG payment standard for disease groups and will provide separate payment. It supports the rapid listing of innovative drugs through a green channel, without including them in the basic medical insurance self-payment rate indicators, and ensures supply through "dual-channel" pharmacies. It encourages the rapid listing of Category 1 innovative drugs within 1 month of approval and prioritizes their use in Beijing's medical institutions with key support, which can be filed without being included in the basic medical insurance self-payment rate indicators.

To align with national-level regulatory updates, the 30-working-day review channel applies to Category 1 innovative drugs, including traditional Chinese medicine, chemical drugs, and biologics. Eligible applications must meet one of the following conditions:

Be part of a national key R&D initiative with evident clinical value and comprehensive innovation support;
Be listed under the NMPA Drug Evaluation Center’s “Children’s Drug Starlight Program” or “Rare Disease Care Program”;
Be involved in globally synchronized R&D, including Phase I–III international multicenter clinical trials or China-led global studies.

Applicants must submit evidence of completed ethical review, verified investigator qualifications, and institutional compliance. They must also demonstrate coordination with trial institutions before filing and commit to initiating the clinical trial (first informed consent signed) within 12 weeks of approval.

In cases where technical review meetings (e.g., expert consultations) are required and the review cannot be completed within 30 working days, NMPA will inform the applicant. The timeline will then follow a 60-working-day implied approval period.

Shenzhen's Support Measures for Innovative Drugs and Medical Devices

The Shenzhen Development and Reform Commission has issued the "Several Measures for Full-Chain Support of the Development of Medicines and Medical Devices in Shenzhen" (hereinafter referred to as the "Measures"), focusing on nine major aspects: research and innovation, artificial intelligence applications, clinical trials, registration and approval, production and manufacturing, promotion and application, corporate internationalization, talent and financial empowerment, and investment promotion. It proposes 32 specific measures.

In terms of market access for innovative drugs and medical devices, Shenzhen continues to improve the procurement model of drugs and medical devices. It has opened a green channel for listing on the Shenzhen Medical Centralized Procurement Platform. The time from the declaration and acceptance of drugs and medical consumables in the Guangdong Province Drug and Medical Consumables Procurement Management Subsystem to the completion of listing on the Shenzhen Medical Centralized Procurement Platform does not exceed 15 working days. At the same time, it encourages public medical institutions to hold a pharmaceutical affairs meeting within 1 month after the release of the national medical insurance negotiation drug directory and to equip and use drugs according to clinical needs and hospital characteristics based on the "full matching" principle. These policies effectively solve the pain point of "high-priced drugs and medical devices entering hospitals" and provide strong support for the market access and clinical application of innovative drugs and medical devices.

In addition, both Shenzhen and Beijing are exploring the linkage between commercial insurance and innovative drugs and medical devices, encouraging the purchase of innovative drug and medical device insurance with personal medical insurance accounts, and promoting the development of commercial health insurance products that cover more innovative drugs and medical devices to expand the accessibility of drugs and medical devices and activate the market's payment capacity. Overall, the new policies provide new opportunities for the development of the innovative drug and medical device industry through a "triple arrow" approach of "accelerating access + optimizing payment + capital injection."

Impact on International Companies

The new policies emphasize the rapid listing and accelerated clinical application of innovative drugs and medical devices, which means that foreign companies can prioritize the registration and listing of innovative products in China. Secondly, changes in medical insurance payment policies, such as Beijing's separate payment for eligible innovative drugs without including them in the DRG payment standard for disease groups, mean that innovative drugs and medical devices will not be restricted by medical insurance fund payments and thus have a broader market prospect.

The June 2025 update from NMPA introduces national-level eligibility and documentation standards that international companies must now observe in addition to local-level procedures. These include ethical review compliance, global trial alignment, and time-bound clinical initiation requirements.

These changes provide a more friendly market environment for international companies but also require companies to pay more attention to policy dynamics to ensure compliance and maximize the use of policy advantages.

Further Information

To read the original announcement about the support measures for innovative drugs and medical devices released by Beijing and Shenzhen on April 7, 2024, please click here.

If you are a pharmaceutical or medical device manufacturer with questions about how long it takes or how much it costs to register your product for the China market, please contact Cisema.