To further optimize the foreign investment environment, promote the high-quality development in the pharmaceutical industry, improve the drug accessibility, and meet our people's need, in accordance with the requirements of the Opinions on Further Optimizing the Foreign Investment Environment and Increasing the Efforts to Attract Foreign Investments (GF [2023] No. 11) issued by State Council, and the NMPA Announcement on Provisions for Post-approval Changes of Drugs (Interim) (No. 8, 2021), regarding the optimization of the application procedures for marketing and registration of drugs manufactured overseas and marketed in China to be transferred to domestic manufacturing, the relevant matters are hereby announced as follows:

I. For drugs manufactured overseas and marketed in China to be transferred to domestic manufacturing, domestic applicants shall submit the application according to the requirements and procedures for drug marketing registration application.

II. For drugs manufactured overseas and marketed in China to be transferred to domestic manufacturing, applicants can submit the original application dossiers of the overseas-manufactured drugs, along with the relevant research data on the transfer to domestic production, in order to support the drug marketing registration application. The specific requirements for the dossiers will be developed and issued by the Center for Drug Evaluation of NMPA.

III. The NMPA shall include the application for marketing and registration of originator chemical drugs and biological products to be transferred to domestic manufacturing in the scope of priority review and approval.

It is hereby announced.

National Medical Products Administration

April 19, 2024