The revised edition of Drug Registration Regulation have been finished recently. SFDA have formally issued the new edition as SFDA order No. 28 on July 10th, and new edition will be put into practice from October 1th, 2007.
The import changes include three aspects:
(1)Enfrocing the requirements for the safety of drugs, more strict for market approvals of drugs
New edition enforces the examination for the facticity of registration data and drug sample. For insuring the safety of drugs from the headstream, fraud behavior in the R&D and registration process will be stricken heavily.
(2) Restructuring supervision system, responsibility definite, enforcing restriction system of official's right to stop the "black case work" and let the process of drug registration under social supervision.
(3) Increasing the standard of examination and approval for drug registration, encouraging the innovation, limiting the low-level repeat.
Several measures are adopted. First, for innovative drugs, "fast track approval" is changed to "special approval". According to the innovation degree, several tracks are set for innovative drugs and the efficiency of examination and approval are increased further.
Second, making certain what kind of drug can win a New Drug Certificate, gold content of innovation drug are increased further.
Third, the technical requirements for changing formulation registration are increased, more concern on technical rationality and development necessity, further instructing the enterprises to register in good order.
Forth, the technical requirements for copy drug registration are increased, emphasizing copy drug should keep equal to the original drug in the aspects of safety, efficiency and quality, further guiding the development and registration of copy drugs.