New Chinese GMP

HISTORY of Chinese GMP guidelines

Updated GMP guidelines were issued by the Chinese SFDA in February 2011, and went into force starting March 1st, 2011.

This blog discusses historical changes in Chinese GMP guidelines and includes links to articles from the World Health Organisation (WHO).

 

 

Chinese GMP updates from 2011

Chinese GMP vs the EU GMP

• The requirements of the revision in 2011 were somewhat similar to the EU GMPs.
• Those updated Chinese GMP requirements were generally consistent with the requirements of the WHO GMP.

Requirements for compliance

• NEW pharmaceutical facilities in China were required to be compliant with the updated Chinese GMP guidelines (2011 version) within 5 years.
• When the 2011 new guidelines were published, established facilities had up to 5 years to become compliant (e.g., to comply with new Chinese GMP guidelines within 5 years of 1 March 2011).

Review an overview of the Chinese GMP guidelines in English by clicking here (2020 document).

Read the World Health Organisation (WHO) publication on Chinese GMP.

Associated articles: click here and here.