CHINESE PHARMACOPOEIA 12ª Edição

The Pharmacopoeia of the People's Republic of China 2025 is the latest five-year edition of China's national pharmacopoeia. It sets standards across traditional Chinese medicines, chemical drugs, biological products,
general chapters and analytical methods. It introduces significant updates to the standards system, testing methods, traditional Chinese medicine quality control and biological products regulation. 

Across its four volumes, the 2025 edition contains 5,911 monographs, including 319 new additions and 3,177 revisions, alongside 10 rejections and 6 reductions. It also incorporates ICH Q4B harmonisation principles for a number
of testing methods. 

Published in four volumes:

     
Volume I - 2,711 monographs for traditional Chinese medicines, including 117 new and 452 revised monographs.

   
Volume II - 2,712 monographs for chemical drugs, including 117 new and 2,387 revised monographs.

      
Volume III - 153 monographs for biological products, including 20 new and 126 revised monographs.

    
Volume IV - 361 general technical chapters and analytical methods, including 35 new analytical methods
and expanded technical guidance. 

Key users include:

  
marketing authorisation holders and pharmaceutical or biopharmaceutical manufacturers

  
regulatory affairs, quality assurance, quality control and laboratory testing teams

international organisations developing, manufacturing, importing or supplying medicines for the Chinese
market 

Further changes highlighted for 2025 include direct harmonisation of 12 testing methods under ICH Q4B principles, parallel codification of four additional methods, and new pesticide-residue and heavy-metal limits for 47 traditional Chinese medicine herbs. The English print edition provides an updated reference for organisations working with current Chinese pharmaceutical standards.