I. Background

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) proposed that "for overseas-marketed drugs that have obtained drug approval certificates in China, allow the import and sale of pre-approval commercial-scale batches that meet requirements". The NMPA has conducted research to refine the relevant requirements and specific measures, and has issued the Announcement on Matters Concerning the Importation of Pre-Approval Commercial-Scale Batch Products of Overseas-Marketed Drugs (hereinafter referred to as the "Announcement"). This aims to shorten the time gap between drug approval and market supply in China, support the early use of innovative and clinically urgently needed drugs for the benefit of patients, and enhance the health and well-being of patients.

II. Specific Measures to Encourage Innovation and Ensure Drug Accessibility

The Announcement implements the principles of the Drug Administration Law with a focus on public health and reflects a clear policy orientation that encourages innovation. It includes new drugs, rare disease treatments, drugs in shortage, and other clinically urgently needed drugs within its scope to meet clinical needs at an early stage. The specific types of drugs covered include:

(I) Innovative drugs and modified new drugs; overseas-marketed 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, as well as drugs with indications for diseases listed in the List of Rare Diseases. These lists are jointly issued by NHC, NMPA, and other departments, aiming to strengthen the supply assurance of drugs in shortage, improve drug accessibility, and meet clinical needs in pediatric care and rare diseases. As of now, the National List of Drugs in Shortage includes 6 varieties; the National List of Key Monitoring Drugs for Clinical Essential and Easy-to-Short-Supplied Drugs includes 57 varieties; the Catalogue of Encouraged Generic Drugs has been released in three batches, totaling 89 varieties; the Catalogue of Pediatric Drugs Encouraged for R&D and Marketing Authorization has been released in five batches, totaling 144 varieties; the List of Rare Diseases has been released in two batches, totaling 207 diseases. Drugs included in these lists or related treatment drugs for rare diseases, which are updated and released in the future, will also fall within the scope of this Announcement.

(III) Drugs that were temporarily imported according to the Work Plan for Temporary Importation of Clinically Urgently Needed Drugs issued by NHC and NMPA. After approval for marketing in China, pre-approval commercial-scale batches may be imported in accordance with the procedures outlined in this Announcement.

(IV) Drugs that have been approved for marketing in China under accelerated registration procedures. The Provisions for Drug Registration provide four accelerated registration procedures for drugs, including the breakthrough therapy drug procedure, conditional approval procedure, priority review and approval procedure, and special review and approval procedure. Drugs that are included in one of these four procedures during clinical trials or review and approval, and are ultimately approved for marketing, are subject to the provisions of this Announcement.

(V) The Announcement applies to imported drugs that have undergone post-marketing changes, which have already been approved for marketing in both overseas markets and China, and already sold and used in China. The applicable drugs are not limited to new drugs, rare disease treatments, drugs in shortage, or other clinically urgently needed drugs, but include all overseas-marketed imported drugs. The prerequisite is that the drug has been used in the clinical treatment of patients in China after being marketed, and both the drug and its post-marketing changes have been approved in China. In the case of filing-type changes, 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.

(VI) Other drugs as specified by the drug regulatory department under the State Council. In response to the ever-changing clinical drug needs, the NMPA will, when appropriate, conduct research and make adjustments to the scope of drug categories applicable under this Announcement.

III. Strict Requirements for the Importation of Pre-Approval Commercial-Scale Batches

While the Announcement encourages the early supply of new drugs, rare disease treatments, drugs in shortage, and other clinically urgently needed drugs, it insists on strict supervision and a quality-first approach.

1. With the exception of innovative drugs and modified new drugs, all other products shall be premised on prior overseas marketing authorization. 2. The pre-approval commercial-scale batches shall comply with Good Manufacturing Practice (GMP). Relevant notification of drug inspection results or certificates of GMP compliance from the country (region) of manufacture shall be provided to confirm the batch's production compliance. 3. The release of the drug after obtaining China's drug approval certificate is a basic condition. This is to ensure that the enterprise fulfills its main responsibility, confirming that the specifications of the pre-approval commercial-scale batches align with the drug registration standards approved by drug regulatory departments in China. The production premise and manufacturing process shall be consistent with the content of China's drug approval documents or the content filed in accordance with the requirements. The instructions and labels shall also be consistent with the approved content or filed content in China. 4. The materials submitted by the enterprise shall comply with the NMPA Announcement on Issuing the Module 1: Administrative Information and Prescribing Information of M4 (No. 6, 2020) and the Announcement on Matters Related to Overseas Manufactured Drug Approval Documents.

IV. Explanation on the Submission of Materials by Enterprise

(I) Regarding the release document. The Announcement set strict requirements for the release stage, but it also fully takes into account the practical situation of enterprises. According to research, the form of the release document from overseas enterprises varies, including forms such as Certificate of Analysis (COA), Certificate of Conformance/Compliance (COC), and Batch Certificate, among others. All these different forms of release documents are recognized. If the release document consists of multiple documents (e.g., COA and Batch Certificate), the final signed date will prevail.

(II) Regarding the Certificate of Pharmaceutical Product. The Certificate of Pharmaceutical Product can serve both as the "document permitting the drug to be marketed" and as the "certificate of GMP compliance". Therefore, when submitting these two documents, the same certificate can be used to fulfill both requirements.

(III) The material submission requirements outlined in the Announcement are generally consistent with the requirements for drug marketing authorization registration applications. Therefore, in certain circumstances, certain materials may be exempt from submission. These include:

(1) As stated in the Decision on Adjusting the Matters Related to Management of Import Drug Registration issued by the former China Food and Drug Administration in 2017, "For new chemical drugs for import drug marketing applications and innovative biologics for therapeutic use, the requirement to obtain marketing approval from the country or region where the overseas manufacturer is located is canceled". 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.

(2) As clarified in Requirements for Changes and Application Materials for Marketed Chemical Drugs and Biologics issued by the NMPA in 2021, "Except for changes involving the Marketing Authorization Holder (MAH), the registered address of the MAH, manufacturer, the production address, and the drug specifications, if the overseas drug regulatory authority cannot issue relevant certificates regarding the changes, the applicant may provide an explanation in accordance with local laws and regulations". The Announcement follows this provision and exempts the submission of certificates regarding the permitted drug change when the overseas drug regulatory authority is unable to provide such a document or there is no publicly available information from the overseas drug regulatory authority, provided that the applicant submits a written explanation. Note that the content of this written explanation should generally align with the explanation provided at the time of submitting the change application.

(3) The Announcement stipulates that if the product applied for import filing is a commercial-scale batch prior to approval of post-marketing approval changes, and if, according to China's registration management requirements, the supplementary application for such changes does not require the submission of the notification of drug inspection results or certificates of GMP compliance, then the applicant is exempt from submitting these documents when applying for import filing. However, a written explanation shall be provided. This exemption takes into account that only certain change applications require the submission of notification of drug inspection results or certificates of GMP compliance (for example, the Center for Drug Evaluation of NMPA’s current guidelines for accepting and reviewing changes to chemical drugs and biologics mention that "for changes to the overseas manufacturing premise, a certificate from the overseas drug regulatory authority confirming that the manufacturing premise complies with Good Manufacturing Practice is required"). For changes that do not require the submission of such documents during the supplementary application, the same exemption applies during the import filing for commercial-scale batches prior to approval of approval-related changes. However, a written explanation shall be provided, stating that the supplementary application for the change did not require the submission of notification of drug inspection results or certificates of GMP compliance.

V. Requirements for the Domestic Responsible Person

The Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders officially came into force on July 1, 2025. According to these provisions, the MAH of imported drugs shall legally designate a domestic responsible person to fulfill their legal obligations within China. The MAH and its designated domestic responsible person shall strengthen risk management of pre-approval commercial-scale batches. If a domestic responsible person has not been designated, the application for import filing of pre-approval commercial-scale batches cannot be processed in accordance with this Announcement.

To facilitate the application process for the domestic responsible person, this Announcement provides a template for the application letter. The domestic responsible person only needs to fill in the relevant information and select the applicable situation. However, the domestic responsible person shall carefully confirm with the MAH, review the relevant materials, and take responsibility for the authenticity and accuracy of the submitted materials. In cases where the submitted materials are in doubt or there are contradictions between materials from different enterprises, the drug regulatory departments will conduct targeted inspection. Any issues found will be dealt with strictly in accordance with all applicable laws and regulations.