In order to further optimize the foreign investment environment, promote the high-quality development of the pharmaceutical industry, improve the accessibility of drugs, and meet the needs of the people, According to The State Council's "Opinions on Further Optimizing the Foreign Investment Environment and Increasing efforts to attract Foreign Investment" (Guofa (2023) No. 11) and the State Food and Drug Administration's "Measures for the Administration of Drug Changes after the Market (Trial)" (Announcement No. 8 of 2021), To optimize the application procedures for listing registration applications for drugs produced overseas that have been listed in China and transferred to drugs produced in China, the relevant matters are hereby announced as follows:

1. If overseas-produced drugs that have been marketed in China are transferred to domestic production, the domestic applicant shall apply in accordance with the requirements and procedures for drug marketing registration applications.

2. If an overseas-produced drug that has been marketed in the country is transferred to domestic production, the relevant pharmaceutical, non-clinical research and clinical research materials (when applicable) can be submitted to the original registration application materials of the overseas-produced drug, and the relevant research transferred to domestic production can be submitted. Information and specific application information requirements will be formulated and released separately by the Drug Evaluation Center of the State Food and Drug Administration.

3. The State Food and Drug Administration will include priority review and approval applications for drug marketing registration applications where original research chemicals and biological products are transferred to domestic production.

Special announcement.