In China, almost all drugs for which application for marketing approval is made needs to be examined in clinical trials including new drugs, import, and generic drugs. The authorities will accelerate review for the following applications: the first application for clinical studies of the same drug, the first application of a "new drug" which has therapeutic effect for difficult, life-threatening and serious illnesses (AIDS, tumor, rare diseases). Exemptions or reductions in clinical trials may be made for an application of imports of orphan drugs and AIDS drugs.
