In this article, we’d like to draw your attention to three recent regulatory updates in China’s life science sector. These updates involve incentives for locally-manufacturing approved foreign drugs, future supporting measures of the Beijing government, and the updated Good Supply Practices for medical devices.
Announcement on Matters Related to Optimizing the Application for Marketing Authorization of Approved Overseas-manufactured Drugs Transferring into Domestic Manufacturing (Draft for Public Comments)
On January 24, 2024, China's National Medical Products Administration (“NMPA”) issued the Announcement on Matters Related to Optimizing the Application for Marketing Authorization of Approved Overseas-manufactured Drugs Transferring into Domestic Manufacturing (Draft for Public Comments), which emphasizes that an application for marketing authorization of such domestically-manufactured drugs must be filed by the domestic applicant. The relevant pharmacological, non-clinical and clinical research information to be filed in the domestic drug application could be the original registration application information of the overseas-manufactured drugs, along with the research information of the transferred-to-domestic manufacturing. Furthermore, the NMPA gives the priority review and approval benefit for such applications where approved original foreign chemical drugs and biologicals are to be switched to domestic manufacturing in China. The rule is still in draft form. We will keep an eye on any developments.
State Council’s Approval of the Work Program to Support Beijing in Constructing the Comprehensive Demonstration Zone for Deepening the Expansion and Opening Up of the State’s Service Industry
On November 18, 2023, the State Council released its approval of the Work Program to Support Beijing in Constructing the Comprehensive Demonstration Zone for Deepening the Expansion and Opening Up of the State’s Service Industry (the “Work Program”).
The Work Program outlines several principles and tasks for the Beijing government to deepen its reform and expand the openness in telecommunications, life science and healthcare, financial services, cultural education. In particular, the Work Program provides that the Beijing government plans to, amongst others, (i) support qualified medical institutions to conduct clinical trials on stem cells; (ii) support international cooperation in stem cell and gene research and development; (iii) promote the facilitation of human genetic resources management services for Hong Kong and Macau enterprises in Beijing; (iv) support the establishment of green channels for imported drugs and medical devices in Beijing that are urgently needed for clinical purposes; (v) promote the application of real-world data in medical technology research; and (vi) establishing a multisectoral, full-process, coordinated regulatory system for cutting-edge biomedical fields.
Good Supply Practices for Medical Devices
On December 4, 2023, the NMPA released an updated Good Supply Practices for Medical Devices (“GSP”), which will become effective on July 1, 2024 and replace the currently in-effect GSP (released on December 12, 2014). It is said that the new GSP is released to accommodate the rapid development of the medical device industry and incorporate changes in other medical device regulations (for example, regulations in respect of online sales, and third-party logistics).
Many updates in the new GSP are related to quality management, the Chinese regulators’ key topic throughout these years, but look stricter and more detailed. For instance, the new GSP requires medical device distributors to establish a set of quality management system documents, which shall cover at least 24 aspects of manufacturing control, including staffing and different procedures in the whole lifecycle of medical device products. Further, medical device distributors shall also make records of the whole process of their distribution activities, covering at least 19 aspects, including supplier qualifications, purchase agreements, inspection records, acceptance records, storage records, etc. Different from the currently in-effect GSP, the new GSP requires Class II and III medical device distributors to sell medical devices to entities with “reasonable using necessity”, and request statements on reasonable using necessity before selling.
Before it becomes effective on July 1, 2024, it will be advisable to compare these more detailed and comprehensive requirements with the existing quality management procedures in your companies and bridge the gaps (if any).
Next steps
Chinese authorities are, on the one hand, strengthening its supervision in the industry and, on the other hand, willingly providing more incentives or favorable policies for market participants. It is advisable to closely monitoring the regulatory trends and actions, and get ready to adhere to any applicable requirements in time.
Authored by Roy Zou, Lu Zhou, and Jessie Xie.
