Understanding New Regulations for Reliable Pharmaceutical Packaging

To: Provincial and regional drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government and the Xinjiang Production and Construction Corps; the Center for Drug Evaluation, the Center for Food and Drug Inspection, the Special Drug Inspection Center and the Information Center of the NMPA:

To implement the Drug Administration Law, the Provisions for Drug Registration and the Provisions for Drug Production Supervision and Administration, and to support the implementation of the Pharmaceutical Excipients Annex and the Pharmaceutical Packaging Materials Annex of the GMP (2010 Revision), and to guide drug regulatory departments in conducting inspections scientifically, the NMPA has organized the formulation of the Inspection Guidelines for the Pharmaceutical Excipients Annex and the Inspection Guidelines for the Pharmaceutical Packaging Materials Annex, hereby issued for compliance, with the following work requirements:

1. Provincial drug regulatory departments shall strictly implement territorial regulatory responsibilities, and in accordance with the Drug Administration Law, the Provisions for Drug Production Supervision and Administration and the annexes of the GMP (2010 Revision), conduct supervision and inspection of pharmaceutical excipient and packaging material manufacturers with Status "A" registration within their jurisdictions at least once every five years.

2. Provincial drug regulatory departments shall make full use of the CDE registration platform information to keep abreast of excipient and packaging material manufacturers within their jurisdictions and implement risk-based targeted supervision. When formulating annual inspection plans, provincial departments shall include excipients and packaging materials, and considering actual regulatory conditions and enterprise inspection regulations, integrate inspection tasks without compromising inspection purposes and quality, promote precise inspection, prevent duplicate inspections and improve inspection efficiency.

3. The provincial drug regulatory department where the MAH is located may conduct necessary extended inspections according to actual regulatory needs. Extended inspections may be conducted directly, or jointly with, or delegated to, the provincial drug regulatory department where the excipient or packaging material manufacturer is located.

4. The organization and implementation of inspections, inspection procedures, documentation requirements and result handling rules may follow the Measures for the Administration of Drug Inspection (Trial) (NMPA [2023] No. 26), the Working Procedures for GMP Compliance Inspection (Trial) (NMPA [2023] No. 86) and other requirements, or relevant procedures may be simplified on a compliant basis according to regulatory realities.

5. After inspection, inspection reports and handling information shall be promptly uploaded to the drug inspection report collection module of the drug business application system of the NMPA smart supervision platform, continuously improving the regulatory files for excipients and packaging materials. Provincial departments shall strengthen coordination and establish sound mechanisms for information notification, exchange, joint investigation and sharing, enhancing regulatory synergy across inspection, sampling, monitoring and enforcement.

6. Where companies are found not to have complied with the excipients annex or the packaging materials annex or other suspected violations, they shall be investigated and punished according to law. Where problems are found in extended inspections, the provincial department where the MAH is located shall promptly inform the provincial department where the manufacturer is located, which shall dispose of them according to law. The provincial department where the MAH is located shall comprehensively assess inspection results in light of the actual use of the excipients and packaging materials in drugs, and take effective risk prevention and control measures for the drugs involved based on the assessment.

7. Provincial drug regulatory departments shall strengthen policy promotion and education and training, urging and guiding excipient and packaging material manufacturers within their jurisdictions to strictly manage production quality in accordance with the NMPA Announcement on Releasing the Pharmaceutical Excipients Annex and the Pharmaceutical Packaging Materials Annex of the GMP (2010 Revision) (No. 1 of 2025) and the guidelines attached to this notice, ensuring continuous compliance of production processes.

General Office of the National Medical Products Administration

November 18, 2025