Live Online Training: China GMP and Registration of APIs

In a relatively short period of time, China has become the leading global supplier of APIs in terms of volume. China is the world’s leading producer and exporter of active pharmaceutical ingredients (APIs) by volume, accounting for 20% of total global API output. According to WHO China produces over 2000 APIs, with annual production capacity exceeding 2 million tons.¹

China first introduced GMP in 1988, and the latest GMP regulations are the 2010 revised edition of Good Manufacturing Practice for Pharmaceutical Products (with effect from 1 March 2011). While CFDA is responsible for developing regulations and standards for GMP, it is mainly provincial and local authorities that are responsible for inspection and certification.¹

The understanding of GMP and Registration Procedures for APIs are thus important to know and understand.

This online training course provides an overview of the legal requirements regarding APIs in China.

¹Source: WHO Report https://www.who.int/phi/publications/ 2081China020517.pdf?ua=1

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