Chinese Pharmacopoeia will gradually improve the standard system of drug packaging materials

Release time:

2021-08-17 15:00

Recently, the State Pharmacopoeia Commission held a seminar on the standard system of drug packaging materials in Beijing. Relevant personnel from the Drug Registration Department and Supervision Department of the State Administration, the China Food and Drug Control Institute, the Drug Evaluation Center and the Pharmacopoeia Commission attended the meeting.

The Pharmacopoeia Committee first briefly introduced the evaluation of the implementation of the existing standards for pharmaceutical packaging materials and the ideas and progress of the construction of the standard system for pharmaceutical packaging materials in the Chinese Pharmacopoeia. On behalf of the drafting group of the General Principles of Glass, the China Institute for Food and Drug Control introduced the drafting ideas and progress of the General Principles of Glass and the supporting general testing methods. The China Pharmaceutical Packaging Association introduced the general situation of domestic and foreign standards for pharmaceutical packaging materials and the industry's feedback on the new standard system.

Yang Zhaopeng, deputy secretary-general of the Pharmacopoeia Commission, emphasized that the construction of the standard system for pharmaceutical packaging materials in the Chinese Pharmacopoeia should be accelerated. In the formulation of the standard for pharmaceutical packaging materials, the "four characteristics" of pharmaceutical packaging materials (I. e. protection, functionality, safety and compatibility) should be fully reflected, and the standardization and integrity of the standard system should be highlighted. We should give full play to the core role of the pharmacopoeia standard code, and make up for the short board of the pharmacopoeia drug packaging material standard, so that the "Chinese Pharmacopoeia" drug packaging material standard can better serve the review and approval and post-marketing supervision, and can better promote the high-quality development of drug packaging materials and the pharmaceutical industry.

new angrun advisory interpretation:

Judging from the current situation of drug packaging material registration, the existing drug packaging material standards are mainly based on the original drug packaging material registration system. Although the 2020 edition of the Chinese Pharmacopoeia has included some testing methods for drug packaging materials, it can no longer meet the needs of the current related review and approval and industry development. It is hoped that the high-quality and efficient development of China's drug packaging material industry will be promoted by rebuilding the drug packaging material standard system of the Chinese Pharmacopoeia.

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