Matters on Import of Commercial Scale Batches Produced Prior to Approval for Drugs Marketed Overseas Clarified

The National Medical Products Administration (NMPA) has issued the Announcement on Matters Related to the Import of Commercial Scale Batches Produced Prior to Approval for Drugs Marketed Overseas (the "Announcement").

The Announcement stipulates that, once overseas marketed drugs are approved for marketing in China (including the cases where a drug approval certificate or a supplementary application approval certificate is obtained), eligible commercial scale batches produced prior to such approval may be imported and sold. Relevant products shall fall into one of six categories, including "innovative drugs or improved drugs". While encouraging the early clinical supply of new drugs, orphan drugs, and drugs in short supply, the Announcement calls for strict regulation and quality first principle. Except for innovative drugs and improved drugs, "overseas marketing" shall become a prerequisite. Commercial scale batches produced prior to approval under import filing application must comply with Good Manufacturing Practices (GMP) and must be supported by a drug inspection result notification from the relevant country (or region) or documentary proof of GMP compliance for the relevant batches.



(Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250930090453177.html)

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