CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling Gon, Yang Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
In addition to these key regulatory updates, there have been other regulatory highlights for drugs and medical devices, respectively as follows. Drug highlights In 2024, several regulations were introduced to strengthen the marketing authorisation hold- er (MAH) system. For example, to strengthen compliance enforcement for MAHs of imported drugs, the NMPA issued the Interim Provisions on the Administration of Domestic Responsible Entities Designated by Overseas MAHs, provid- ing specific obligations and procedural require- ments for MAH domestic responsible entities. Several regulations were also released to regu- late the manufacture and promotion of drugs. In April 2024, the NMPA issued the Announcement on the Optimisation of Registration Application Procedures for the Transfer from Overseas Man- ufacture to Domestic Manufacture for Marketed Drugs in China. The Announcement provides a feasible pathway to localise the production of imported drugs and clarifies the requirements for these transfers. For the manufacture of biological products, the NMPA released the Pilot Work Plan for Segment- ed Production of Biological Products in October 2024, suggesting the feasibility of cross-provin- cial and cross-border production of some spe- cific biological products. With respect to promo- tions, the NMPA released the Draft Measures for the Administration of Pharmaceutical Represent- atives in November 2024, which would regulate the conduct of pharmaceutical representatives and ensure compliance for promotional activities in pharmaceutical academic settings. China also released multiple guidelines to address anti-monopoly issues in the pharmaceu- tical industry. In August 2024, the State Admin-
istration for Market Regulation (the “SAMR” ) issued the Draft Anti-Monopoly Guidelines for the Pharmaceutical Industry, which aim to pro- hibit monopolistic practices and promote fair competition specifically within the pharmaceu- tical market. Medical device highlights China made significant breakthroughs and land- mark developments in the medical device regu- latory framework in 2024. In August, the NMPA released the draft Medical Device Administra- tion Law (the “draft MDAL” ) for public consulta- tion. This is a remarkable milestone, which has been achieved within one year of its inclusion in China’s legislative agenda. The draft MDAL introduces several significant reforms, includ- ing establishing clear pathways for medical device marketing approval transfers, strength- ening oversight of domestic responsible entities, streamlining clinical trial approval processes and proposing the establishment and enhancement of a vigilance system. China has also updated its regulations for innova- tive medical device importation. In July 2024, the NMPA and the NHC issued the Announcement on the Temporary Import and Use of Clinically Urgent Medical Devices for Medical Institutions. This Announcement establishes and refines a nationwide framework for the importation of clinically urgent medical devices, while also inte- grating insights from local pilot programmes. It has paved the way for the temporary importation of medical devices that lack equivalent products marketed in China, facilitating the entry of inno- vative solutions into China. As for the regulations covering medical device clinical trials, in March 2024, the NMPA released the Regulations on the Supervision and Inspec- tion of Medical Device Clinical Trial Institutions
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