Clinical research strategies for imported drugs registration

Investigation on mode of on-site examination in drug registration;

Stability studies in drug registration

The system of drug registration and management in China has gone through the three stages of initiation, formation and completion since the founding of new China, and since 1985 when the Law of Drug Management began to be enforced in particular, the reform of examination and evaluation mechanisms of drugs has ever gone deeply.

Results and Conclusion Through the American experience,active steps to amend the"Drug Administration Law,"to improve the level of R & D of new drugs and new drug registration capability.

It is concluded that proper size and period of the discovery window are important .