The National Medical Products Administration (NMPA) has released a draft proposal titled “Optimizing the Market Approval Filing Matters for Overseas Drugs Already Marketed in China to Be Manufactured in China.” The document is open for public feedback from January 25 to February 23, 2024.
The draft proposal outlines several key points:
- For drugs that are manufactured overseas and have already been approved for the Chinese market, and are to be transferred to domestic production, the domestic applicant may file in accordance with the requirements and procedures of a drug registration application.
- For drugs that are manufactured overseas, listed in China, and transferred to domestic production, relevant pharmaceutical, non-clinical, and clinical research materials (when applicable) can be submitted alongside the original registration application materials, including relevant research materials transferred to domestic production.
- The NMPA will include the application for market registration of originator chemical drugs and biological products to be transferred to domestic production within the scope of the priority review and approval channel.
The draft proposal aims to streamline the process for drugs manufactured overseas that are already marketed in China and are planned to be produced domestically, ensuring a more efficient regulatory pathway.- Flcube.com
