The Pharmacopoeia of the People’s Republic of China (2025 Edition), released by the National Medical Products Administration and National Health Commission, has been approved by the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee. The new edition is scheduled for implementation on October 1, 2025.
Regulatory Requirements
From the implementation date, all new drug market filings must comply with the latest edition. For filings accepted before this date but not yet technically evaluated, drug regulatory authorities will conduct assessments and approvals in accordance with the new standards. Any necessary supplementary technical information must be submitted in one go.
Transition Period
Drugs approved between the promulgation of the latest edition and its implementation must meet the new requirements within six months of approval.-Fineline Info & Tech
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