"Different controlling measures will be carried out for solving the problem that pharmaceutical enterprises use the APIs proudced by chemical enterprises to produce finished drugs", Wu Zhen said recently. "Now SFDA had begun to do the general investigation about the situation that chemical enterprise produce APIs."
In China, the active chemical ingredients (ACIs) that can be used to produce finished drugs without further processing are controlled as APIs, but some active chemical ingredients can't be used to produce drugs without further processing aren't controlled as APIs. SFDA began the investigation to know what ACIs the enterprises produce respectively. Then SFDA will implement registration system, on-file system or licencing system for various situations. The intention of the action is to strengthen the supervision of quality.