To implement the relevant requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), and to support the early use of innovative and clinically urgently needed drugs for the benefit of patients, the relevant matters related to the importation of pre-approval commercial-scale batches of overseas-marketed drugs are hereby announced as follows:

I. Applicable Categories of Drugs

For overseas-marketed drugs that have been approved for marketing in China (including those with drug approval certificates or supplementary application approval certificates, the same below), the pre-approval commercial-scale batches that meet the relevant requirements are allowed to be imported and marketed. The relevant products shall fall under one of the following categories:

(I) Originator drugs or modified drugs.

(II) Drugs listed in the National List of Drugs in Shortage, National List of Key Monitoring Drugs for Clinical Essential and Easy-to-Short-Supplied Drugs, Catalogue of Encouraged Generic Drugs, and Catalogue of Pediatric Drugs Encouraged for R&D and Marketing Authorization.

(III) Drugs with indications for diseases listed in the List of Rare Diseases.

(IV) Drugs that were temporarily imported according to the Work Plan for Temporary Importation of Clinically Urgently Needed Drugs before being approved for marketing in China.

(V) Drugs that have been approved for marketing in China under accelerated registration procedures in accordance with the Provisions for Drug Registration.

(VI) Other drugs as specified by the drug regulatory department under the State Council.

II. Conditions and Requirements

In addition to meeting the requirements of the Provisions for Drug Importation, applicants for the filing of pre-approval commercial-scale batches of overseas-marketed drugs shall also meet the following conditions:

(I) The drug has been approved for marketing by the overseas drug regulatory authority. In cases of post-marketing changes, the overseas regulatory authority shall have approved these changes, or the changes shall be filed in accordance with overseas laws and regulations.

(II) The product quality standards shall comply with the drug registration standards approved by China's drug regulatory department. The production premises and manufacturing process shall be consistent with the information specified in China's drug approval documents or the content filed as required. The instructions and labels shall be consistent with the approved content by China's drug regulatory department or filed as required.

(III) The product shall have passed Good Manufacturing Practice (GMP) compliance inspections conducted by China, the country (region) of manufacture, or the country (region) where the drug is registered or marketed (including those under application for registration).

(IV) A release document shall be signed after the drug is approved for market in China.

III. Other Matters

(I) The Marketing Authorization Holder (MAH) and its designated domestic responsible person shall submit an application letter (template provided in Annex 1) and relevant materials (submission requirements provided in Annex 2) in accordance with the requirements outlined in the annexes. The port drug regulatory departments responsible for accepting the import filing applications shall carry out the relevant inspection work (inspection items listed in Annex 3).

(II) For imported drugs that have been approved for marketing both overseas and in China, and are already being sold and used in China, if post-marketing changes occur, the importation of pre-approval commercial-scale batches may refer to this Announcement after the approval of the changes in China. In cases where the changes are categorized as filing-type changes according to the Provisions for the Change Management of Post-Approval Drugs (Interim) and the relevant guidelines, the commercial-scale batches produced before the filing information is disclosed and consistent with the filed information may be imported according to the Provisions for Drug Importation without needing to submit materials as required by this Announcement.

(III) The Announcement follows this provision and exempts the submission of the document permitting the drug to be marketed from the overseas drug regulatory authority when applying for import filing for pre-approval commercial-scale batches of innovative and modified new drugs produced overseas.

(IV) The MAH and its designated domestic responsible person shall strengthen risk management of pre-approval commercial-scale batches. In the case of violations of the provisions of this Announcement, the provincial drug regulatory department where the domestic responsible person of the MAH is located shall handle the case in accordance with all applicable laws and regulations.

It is hereby announced.

National Medical Products Administration

September 29, 2025