Another look at news in the week to March 25

By Barbara Obstoj-Cardwell. Editor

Earlier this month, the China Food and Drug Administration (CFDA) formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs. The reform scheme is an important part of the general reform of the drug and device approval system that the State Council initiated in late 2015, wrote Katherine Wang of law firm Ropes & Gray in International Law Office, elaborating on the situation. The reform scheme's new classification of small molecule drugs differs considerably from the old classification under the Drug Registration Rules.

The reform scheme redefines new drugs and generics. Under the old Drug Registration Rules, 'new drugs' referred to drugs never marketed in China, even if they had been marketed outside of China. Under the new classification, 'new drugs' now refers only to: