China releases new registration policy on chemical drugs

Pharma companies in China who wish to register chemical drugs in the country need to follow the new registration policy released by China’s food and drug administration (CFDA) on March 4, effective immediately, reports The Pharma Letter’s local correspondent Wang Fangqing.

The new policy divides drugs into five categories – novel drugs for the global market, optimized preparations of existing drugs for the global market, first generic drugs (FGD) in China, generics, as well as imported drugs. Specific clarifications for each category are given. For example, a “novel drug” is an innovative, clinically valuable drug with pharmacological effect and clear structure.

Such definition is completely different from the 2007 version, under which the category “novel drugs” was not seen, instead it was “drugs not sold inside and outside China,” and such drugs included preparations and their active pharmaceutical ingredients made from synthetic or semi-synthetic methods, as well as preparations and effective monomer made from extraction of natural substances or fermentation.