To implement relevant regulations such as the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and the Provisions for Drug Manufacturing Supervision and Administration, and to supervise and guide the standardized production of pharmaceutical excipients and pharmaceutical packaging materials manufacturers, the National Medical Products Administration has organized the formulation of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. These serve as supplementary provisions for the Good Manufacturing Practice for Drugs (2010 Revision) in accordance with Article 310 of the Good Manufacturing Practice for Drugs (2010 Revision). They are hereby issued (see Annexes 1 and 2), and the relevant matters concerning the strengthening of the quality supervision of pharmaceutical excipients and pharmaceutical packaging materials are announced as follows:

I. Pharmaceutical Excipients and Pharmaceutical Packaging Materials Manufacturers to Establish a Comprehensive Quality Management System

(1) Implement the primary responsibility for product quality. Pharmaceutical excipient and pharmaceutical packaging material manufacturers shall establish and maintain a comprehensive quality management system in accordance with the requirements of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. They shall allocate appropriate organizations and personnel according to the scale of production, develop detailed management documents and operating procedures, and maintain accurate records. Manufacturers are also required to conduct regular quality assessments on the raw material suppliers used in the production of pharmaceutical excipients and packaging materials. Production shall be organized according to the information registered on the Center for Drug Evaluation of National Medical Products Administration (NMPA) (hereinafter referred to as the CDE) platform for APIs, excipients, and packaging materials, including company names, production addresses, and formulation processes. Each batch of products must undergo inspection based on specifications and can only be released after approval by the quality management department.

(2) Strict change management. Pharmaceutical excipient and pharmaceutical packaging material manufacturers shall establish a change management system in accordance with the requirements of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. Based on risk assessments, they shall classify the types of changes that occur during the production of pharmaceutical excipients and pharmaceutical packaging materials, conduct the necessary studies, and implement changes only after approval from the quality management department. The information on the CDE platform for APIs, excipients, and packaging materials shall be updated, and the drug marketing authorization holder (MAH) must be promptly notified.

For changes that may affect the quality of pharmaceutical excipients and pharmaceutical packaging materials (such as changes in the production process, raw material sources, or production sites), manufacturers shall ensure full communication with the drug MAH during the research process.

(3) Strengthen external communication and cooperation. Pharmaceutical excipient and pharmaceutical packaging material manufacturers shall cooperate with the drug MAH during audits, provide access to relevant areas or facilities, and supply accurate, valid, and complete documents, records, and other relevant materials. They shall also cooperate with the MAH in quality management activities, including complaints, returns, and recalls.

In cases involving entrusted testing, pharmaceutical excipients and packaging material manufacturers shall strictly adhere to the requirements for entrusted testing. They shall sign appropriate quality agreements with the contracted testing institutions to ensure the reliability of the test results.

II. Strengthening the Management of Pharmaceutical Excipients and Pharmaceutical Packaging Materials Usage by MAH

(4) Implement the primary responsibility for drug quality and safety. The MAH shall establish and maintain a comprehensive quality management system, strictly managing the use of pharmaceutical excipients and pharmaceutical packaging materials. The MAH shall sign quality agreements with key pharmaceutical excipient and packaging material manufacturers to ensure that the pharmaceutical excipients and pharmaceutical packaging materials used in drug production meet the required pharmaceutical standards and intended purposes.

(5) Strengthen the audit of suppliers. The MAH shall evaluate and approve all suppliers of pharmaceutical excipients and pharmaceutical packaging materials (including manufacturers and distributors) in accordance with the requirements of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. A supplier quality file shall be established, and regular quality evaluations shall be conducted. In accordance with the principle of risk management, the MAH shall conduct regular on-site audits of the quality management systems of the main suppliers (especially manufacturers) of pharmaceutical excipients and pharmaceutical packaging materials.

(6) Strengthen the quality audit of pharmaceutical excipients and pharmaceutical packaging materials. The MAH shall conduct audits of the quality control and product release capabilities of pharmaceutical excipients and pharmaceutical packaging material manufacturers and conduct incoming inspections in strict accordance with the requirements. If necessary, based on risk assessments and intended use, the MAH shall add incoming inspection items for the pharmaceutical excipients and pharmaceutical packaging materials required for the production of drugs.

(7) Strengthen the management of changes in pharmaceutical excipients and pharmaceutical packaging materials. The MAH shall promptly monitor any changes in the pharmaceutical excipients and pharmaceutical packaging materials being used, assess the impact of these changes on the quality of the drug, and conduct the required studies according to drug change management procedures. Changes shall be implemented only after approval or filing, or reported according to the annual reporting requirements. If a change or addition of pharmaceutical excipients and pharmaceutical packaging materials suppliers is proposed for the drug preparations, the MAH must follow post-approval change management procedures.

III. Strengthening Supervision and Management by Drug Regulatory Authorities

(8) Strengthen supervision and inspection. Provincial drug regulatory authorities shall strengthen policy promotion and urge pharmaceutical excipient and packaging material manufacturers to conduct self-inspections and ensure continuous improvement of their quality management systems according to the requirements of the appendices. Provincial drug regulatory authorities shall use the information on the registration platform for APIs, excipients, and packaging materials of the CDE to carry out supervision and inspections of manufacturers in their jurisdiction whose excipient and packaging material registration status is marked as "A" and urge the manufacturers to organize production in strict accordance with the registered information. They may, according to the actual needs of supervision and the principle of risk management, conduct quality sampling inspections of pharmaceutical excipients and pharmaceutical packaging materials. Provincial drug regulatory authorities where the MAH of drugs are located shall conduct extended inspections when necessary.

(9) Strengthen risk management and enforcement against violations. If a pharmaceutical excipient and pharmaceutical packaging material manufacturer is found to have violated the requirements of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex during the inspection, provincial drug regulatory authorities shall investigate and handle the matter in accordance with Article 126 of the Drug Administration Law and other relevant regulations, and urge the manufacturer to report the situation to the MAH. The MAH shall assess the quality risk of the drug preparation and, if necessary, proactively implement risk control measures. For serious violations or if the manufacturer fails to rectify within the specified time after being ordered to do so, the provincial regulatory authority shall report the inspection results to the CDE. Based on the inspection findings, the CDE will consider adjusting the registration status of the relevant product.

(10) Other matters. This Announcement shall come into force on January 1, 2026. Before the formal implementation, pharmaceutical excipients and pharmaceutical packaging materials manufacturing enterprises shall promptly improve their facilities and equipment and perfect their quality management systems to ensure compliance with the requirements of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex. As of the date of implementation of this Announcement, the Notice on Printing and Issuing the GMP for Pharmaceutical Excipients (GSYJA [2006] No.120) shall be repealed.

It is hereby announced.

National Medical Products Administration

December 27, 2024