In order to further optimize the foreign investment environment, promote the high-quality development of the pharmaceutical industry, improve the accessibility of drugs, and satisfy the need of medication for the public, in accordance with the requirements of the guidelines regarding further optimizing the foreign investment environment and intensifying efforts to attract foreign investments issued by China's State Council and the NMPA announcement on issuing the Provisions for Post-approval Changes of Drugs (Interim), the registration application procedures for drugs manufactured overseas and marketed in China to be transferred to manufacturing in China has been optimized. The relevant matters are hereby announced as follows:

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

　　III. For those registration applications for original chemical drugs and biological products to be transferred to manufacturing in China, the NMPA should include them in the scope of priority review and approval procedures.

　　It is hereby announced.

　　National Medical Products Administration

　　April 19, 2024