The National Medical Products Administration (NMPA) has released the “Drug Standard Management Measures,” a set of guidelines aimed at standardizing and strengthening drug standard management. These measures are designed to ensure rigorous drug standards related to safety, effectiveness, and controllable quality, with the ultimate goal of promoting high-quality development of drugs in China.
Implementation Date and National Drug Standards
The document is set to come into force as of January 1, 2024. The Pharmacopoeia of the China and drug standards promulgated by the NMPA together constitute the national drug standards. The supplementary edition of the Chinese Pharmacopoeia and its corresponding current version hold the same legal effect.
Drug Registration Standards and Public Participation
The quality standards proposed by drug registration applicants, certified by the Center for Drug Evaluation (CDE), and approved by the NMPA when approving drug marketing licenses and supplementary filings by the marketing authorization holder (MAH) are considered drug registration standards. Social organizations, enterprises, institutions, and citizens are encouraged to actively participate in the research and improvement of drug standards. They are invited to increase investment in information, technology, talent, and funding, and to provide reasonable opinions and suggestions for the formulation and revision of drug standards. The formulation and revision of drug registration standards should strengthen the primary responsibility of holders.-Fineline Info & Tech
