New Rules on Local Production of Imported Drugs in China

Summary

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• New rules issued by the National Medical Products Administration aim to encourage the local production of certain pharmaceutical products
• Chinese applicants are specifically targeted by the rules
• Priority review and conditional approval procedures are applied under specific conditions by the rules
• Multinational pharmaceutical companies are likely to find themselves impacted; finding local partners will be essential in some cases

I .   Background

On April 23, 2024, the National Medical Products Administration ("NMPA") of China published new rules on local production of imported drugs in China, namely the Announcement on Matters Relating to Optimizing the Application for Registration of the Marketing of a Domestically Marketed Foreign Produced Pharmaceutical the Production of Which is to Switch to Mainland China (国家药监局关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事项的公告) (2024 No. 49, hereinafter referred to as the "Announcement"). The term "imported drugs" refers to drugs that have been approved and sold in China but are manufactured outside of China . The Announcement clarified that the Chinese applicant must adhere to the requirements and procedures for drug marketing authorization application when applying for transferring manufacturing imported drugs into China. Moreover, according to the Announcement, the applicants may submit the new research materials for local production as supplemental documents, along with the materials previously filed for sale such drugs in China. As to the applications for local production of originator chemical drugs and biologics, the NMPA incorporates them into the category subject to the priority review and approval procedure.