Chinas State Food and Drug Administration

The standard processing period for drug approval according to the MHLW is as follows  

All new drug applications are expected to be in the CTD format according to ICH guidelines (see Section 7.11). Priority reviews are applicable for orphan drugs and those drugs for the treatment of serious illnesses. A restricted approval system has been implemented for emergency drugs to prevent spread of diseases. In this case, the standard review procedure is not applicable. 

China s pharmaceutical market is growing at a very fast pace. The current data show that the total market is around US 20 billion, and it is the ninth largest pharmaceutical country in the world. The Chinese government maintains price control on imported drugs. With China s entry into the World Trade Organization (WTO), tariffs have been reduced from 20% to 6.5%. The projection is that the market size will reach US 60 billion by 2010, and China will be the world s largest market by 2020. 

Drugs are classihed into several categories. These are synthetic drugs, TCM, and biological products. The SFDA stipulates compliance to GMP for medical products, GCP for clinical trials, and GLP for nonclinical drug safety research. 

Exhibit 7.4 Clinical Trials and Selected Drugs Approved in China 

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China State Food and Drug Administration (SFDA)... 

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