Understanding New Regulations for Reliable Pharmaceutical Packaging

To implement the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law, the Provisions for Drug Registration and the Provisions for Drug Production Supervision and Administration, and to supervise and guide standardized production by pharmaceutical excipient and packaging material manufacturers, the NMPA has, under Article 310 of the Good Manufacturing Practice for Drugs (2010 Revision), organized the formulation of the Pharmaceutical Excipients Annex and the Pharmaceutical Packaging Materials Annex as supporting documents of the GMP (2010 Revision), hereby released (see Annexes 1 and 2), and announces the following on strengthening quality supervision of pharmaceutical excipients and packaging materials:

1. Pharmaceutical excipient and packaging material manufacturers shall establish and improve quality management systems

(1) Fulfill primary responsibility for product quality. Manufacturers shall establish and improve quality management systems against the requirements of the excipients annex and the packaging materials annex, staff organizations and personnel commensurate with production scale, establish detailed management documents and operating procedures and keep relevant records, regularly evaluate manufacturers of raw materials used in production, produce according to the company name, production address, formulation process and other information registered on the CDE raw and auxiliary materials and packaging registration platform, and test each batch against quality standards, releasing products only after review and approval by the quality management department.

(2) Strict change management. Manufacturers shall establish a change management system as required by the annexes, determine change categories by risk, conduct corresponding studies, implement only after approval by the quality management department, update the CDE registration platform information and inform MAHs promptly.

For changes that may affect the quality of excipients or packaging materials (such as changes in production processes, raw material sources or production sites), full communication with the MAH shall take place during the study.

(3) Strengthen external communication and collaboration. Manufacturers shall cooperate with MAH audits, open relevant premises or areas, provide true, valid and complete documents, records and other materials, and cooperate in MAH quality management activities including complaints, returns and recalls.

Where commissioned testing is involved, manufacturers shall strictly follow the relevant requirements of commissioned testing, sign testing quality agreements with the commissioned testing institution, and ensure the reliability of test results.

2. MAHs shall strengthen the management of excipient and packaging material use

(4) Fulfill primary responsibility for drug quality and safety. MAHs shall establish and improve quality management systems, strictly manage the use of excipients and packaging materials, sign quality agreements with major excipient and packaging material manufacturers, and ensure that the excipients and packaging materials needed for drug production meet medicinal requirements and intended uses.

(5) Strengthen supplier audits. MAHs shall evaluate and approve all excipient and packaging material suppliers (including manufacturers and distributors) needed for drug production against the annex requirements, establish supplier quality files and conduct regular quality evaluations. Based on risk management principles, on-site audits of the quality management systems of major suppliers (especially manufacturers) shall be conducted regularly.

(6) Strengthen quality review of excipients and packaging materials. MAHs shall audit the quality control and product release capability of excipient and packaging material manufacturers and strictly perform incoming inspection as required. Where necessary, MAHs shall add incoming test items for excipients and packaging materials based on risk assessment and intended use.

(7) Strengthen change management of excipients and packaging materials. MAHs shall keep abreast of changes in the excipients and packaging materials used, evaluate the impact of changes on drug quality, conduct corresponding studies under drug change management requirements, implement after approval or filing, or report as required by annual reporting. Where a drug formulation intends to change or add excipient or packaging material suppliers, MAHs shall proceed according to post-marketing change management requirements.

3. Drug regulatory departments shall strengthen supervision

(8) Strengthen supervision and inspection. Provincial drug regulatory departments shall strengthen policy promotion, urge manufacturers to conduct self-inspection, and continuously improve quality management against the annex requirements. Provincial departments shall use the CDE registration platform information to organize supervision and inspection of manufacturers with Status "A" registration within their jurisdictions, urging them to produce strictly according to registered information; quality sampling inspections may be conducted as needed based on regulatory realities and risk management principles. The provincial department where the MAH is located may conduct extended inspections when necessary.

(9) Strengthen risk disposal and investigation of violations. Where manufacturers are found not to have complied with the annexes, provincial drug regulatory departments shall investigate and dispose in accordance with Article 126 of the Drug Administration Law and other provisions, and urge the company to inform MAHs of the situation. MAHs shall evaluate the quality risk of drug formulations and take risk control measures proactively where necessary. For serious cases or those failing to rectify within the ordered time limit, provincial departments shall also report inspection findings to the CDE, which will study adjusting the registration status of the relevant products.

(10) Other matters. This announcement takes effect from January 1, 2026. Before formal implementation, manufacturers should promptly improve facilities and equipment and refine quality management systems to meet the annex requirements. From the date of effectiveness, the Notice on Issuing the Good Manufacturing Practice for Pharmaceutical Excipients (SFDA [2006] No. 120) is repealed.

This announcement is hereby given.

Annexes: 1. Pharmaceutical Excipients; 2. Pharmaceutical Packaging Materials

National Medical Products Administration

December 27, 2024