In order to implement the relevant provisions of the Drug Administration Law of the People's Republic of China, the Implementation Regulations of the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, and the Measures for the Supervision and Administration of Drug Production, and to supervise and guide the standardized production of pharmaceutical excipients and packaging materials, the National Medical Products Administration, in accordance with Article 310 of the "Good Manufacturing Practice for Drugs (Revised in 2010)", has organized the development of appendices for pharmaceutical excipients and packaging materials as supporting documents for the "Good Manufacturing Practice for Drugs (Revised in 2010)". They are now released (see attachments 1 and 2), and the relevant matters on strengthening the quality supervision of pharmaceutical excipients and packaging materials are announced as follows:
1、 Establishment and improvement of quality management system for pharmaceutical excipients and packaging materials production enterprises
（1） Implement the main responsibility for product quality. Pharmaceutical excipients and pharmaceutical packaging materials production enterprises shall establish and improve their quality management system in accordance with the requirements of the Appendix of Pharmaceutical excipients and the Appendix of Pharmaceutical Packaging Materials, equip institutions and personnel that are suitable for production scale, establish detailed management documents and operating procedures, and keep relevant records. Regular quality assessments shall be conducted on the production enterprises of raw materials used in the production of pharmaceutical excipients and pharmaceutical packaging materials. Production shall be organized according to the enterprise name, production address, formula process and other information registered on the Raw and Auxiliary Packaging Registration Platform of the Drug Evaluation Center (hereinafter referred to as the Drug Evaluation Center) of the National Medical Products Administration. Each batch of products shall be inspected according to quality standards and approved by the quality management department before release.
（2） Strict change management. Pharmaceutical excipients and pharmaceutical packaging materials production enterprises shall establish a change management system in accordance with the requirements of the Appendix of Pharmaceutical excipients and the Appendix of Pharmaceutical Packaging Materials, determine the types of changes in the production process of pharmaceutical excipients and pharmaceutical packaging materials based on risks, conduct corresponding research, and implement them only after approval by the quality management department. They shall also update the original auxiliary package registration platform information of the drug review center and promptly inform the drug marketing authorization holder.
For changes that may affect the quality of pharmaceutical excipients and packaging materials (such as changes in production processes, raw material sources, production sites, etc.), sufficient communication should be made with the drug marketing authorization holder during the research process.
（3） Strengthen external communication and collaboration. Pharmaceutical excipients and drug packaging manufacturers shall cooperate with drug marketing authorization holders to conduct audits, open relevant venues or areas, and provide authentic, effective, and complete documents, records, and other related materials; Cooperate with drug marketing authorization holders to carry out quality management activities, including complaints, returns, and recalls.
If entrusted inspection is involved, pharmaceutical excipients and drug packaging manufacturers shall strictly follow the relevant requirements of entrusted inspection, sign corresponding inspection quality agreements with the entrusted inspection agency, and ensure the reliability of the inspection results.
2、 Drug marketing authorization holders strengthen the management of the use of pharmaceutical excipients and packaging materials
（4） Implement the main responsibility for drug quality and safety. The holder of a drug marketing authorization shall establish and improve a quality management system, strictly manage the use of pharmaceutical excipients and packaging materials, sign quality agreements with major pharmaceutical excipient and packaging material manufacturers, and ensure that the pharmaceutical excipients and packaging materials required for drug production meet the requirements and intended use.
（5） Strengthen supplier audits. The holder of the drug marketing authorization shall evaluate and approve all suppliers (including production enterprises and distributors) of pharmaceutical excipients and packaging materials required for the production of the drug in accordance with the requirements of the appendix of pharmaceutical excipients and packaging materials, establish supplier quality files, and conduct quality assessments on the agreed supply period. According to risk management principles, regular on-site audits are conducted on the quality management systems of major pharmaceutical excipients and drug packaging suppliers (especially production enterprises).
（6） Strengthen the quality audit of pharmaceutical excipients and packaging materials. The holder of a drug marketing authorization shall conduct an audit of the quality control and product release capabilities of pharmaceutical excipients and packaging materials manufacturing enterprises, and strictly conduct incoming inspections in accordance with requirements. When necessary, the holder of the drug marketing authorization shall add factory inspection items to the pharmaceutical excipients and packaging materials required for the production of drugs based on risk assessment and intended use.
（7） Strengthen the management of changes in pharmaceutical excipients and packaging materials. The holder of drug marketing authorization shall promptly grasp the changes in the use of pharmaceutical excipients and packaging materials, evaluate the impact of changes on drug quality, and conduct corresponding research in accordance with drug change management requirements. After approval and filing, it shall be implemented or reported in accordance with annual reporting requirements. If a pharmaceutical preparation intends to change or add suppliers of pharmaceutical excipients or packaging materials, the holder of the drug marketing authorization shall handle it in accordance with the requirements for post marketing change management of the drug.
3、 Drug regulatory authorities strengthen supervision and management
（8） Strengthen supervision and inspection. Provincial drug regulatory authorities should strengthen policy promotion, supervise the self-examination of pharmaceutical excipients and packaging materials production enterprises, and continuously improve their quality management level in accordance with the requirements of the appendix. Provincial drug regulatory authorities should use the information on the original auxiliary package registration platform of the drug review center to organize supervision and inspection of production enterprises with a registration status of "A" for pharmaceutical excipients and packaging materials within the administrative region, and urge enterprises to strictly organize production according to the registration information; Quality inspections can be conducted on pharmaceutical excipients and packaging materials based on regulatory needs and risk management principles. When necessary, the provincial drug regulatory department where the holder of the drug marketing authorization is located shall conduct extended inspections.
（9） Strengthen risk management and investigate illegal activities. If it is found during inspection that pharmaceutical excipients and drug packaging material production enterprises have not complied with the appendix of pharmaceutical excipients and drug packaging materials, the provincial drug regulatory department shall investigate and dispose of them in accordance with Article 126 of the Drug Administration Law and other provisions, and urge the enterprises to report the relevant situation to the drug marketing authorization holder. The holder of a drug marketing authorization shall assess the quality risks of the drug formulation and take proactive risk control measures when necessary. For those with serious circumstances or those who are ordered to make corrections within a specified period but fail to do so, the provincial drug regulatory department shall also report the inspection results to the drug review center; The drug review center will adjust the registration status of corresponding products based on the inspection results.
（10） Other matters. This announcement shall come into effect on January 1, 2026. Before formal implementation, pharmaceutical excipients and drug packaging manufacturers should promptly improve their facilities and equipment, and perfect their quality management systems to ensure compliance with the requirements of the appendices for pharmaceutical excipients and drug packaging materials. From the date of implementation of this announcement, the Notice on Issuing the Quality Management Standards for the Production of Medicinal Excipients (State Food and Drug Administration [2006] No. 120) issued by the former State Food and Drug Administration is abolished.