In the past 10 years, Chinese drug administration authorities have promulgated a number of new regulations regarding clinical use of drugs and have approved a large number of clinical trials, particularly of newer drugs. The experience gained from such trials provides a base of knowledge upon which Chinese authorities can now determine how to implement ICH and determine China's participation in international clinical trials. However, Chinese authorities will need to consider how to facilitate the research purposes implicit in IND, as well as appropriate reductions in trials for drugs, which have already been extensively tested in other markets. Also, Chinese authorities should consider eliminating the requirement of conducting a small-scale bioequivalence trial when a drug is localized, i.e. switched from import status to local manufacture.
