In 2010, the China Food and Drug Administration (CFDA ) published revised Good Manufacturing Practice (GMP) regulations . Industry was given a grace period for implementation, particularly since CFDA lacked the resources at the time to fully inspect the large number of facilities available and enforce the regulations. CFDA now has published the implementation plan and issued letters to local Chinese FDA inspectorates (in Chinese only), relating to specific en...

China is a mysterious and interesting country for the regulatory professional. It is of interest because of its enormous market potential (nearly a fifth of the world’s population lives in the People’s Republic of China) and the fact that China is one of the most important manufacturers of active pharmaceutical ingredients (APIs) for the EU and US. China exported 1.2 million tons of APIs to the EU and 0.6 million tons to the US in 2013. China is somewhat mysterious becau...