In 2009, China accepted a total of 3,357 applications for drug registration, which showed a significant change compared with the peak of tens of thousands or even 20,000 per year. This is the data disclosed by Shao Mingli, director of the State Food and Drug Administration, at the National Food and Drug Administration Conference held on January 18.
Shao Mingli pointed out that most of the new drugs that were previously declared were tinkering, and the new drugs were not new. In the past two years, the State Food and Drug Administration has fully implemented the newly revised drug registration management measures, raising the threshold for registration approval and reducing low-level duplicate declarations. In the 3,357 registration applications filed in 2009, the proportion of new drug applications has reached 35%, and the number and structure of registrations have remained at a relatively reasonable level for two consecutive years.
It is reported that in order to promote the optimization and upgrading of the pharmaceutical industry and technological progress, the Drug Registration Department of the State Food and Drug Administration has also promulgated the "Measures for the Implementation of the Special Approval Procedure for Drug Registration", setting up different channels for innovative varieties; To regulate the registration of drug technology transfer from the policy, encourage pharmaceutical companies to innovate and strengthen their technology, and promote the transformation of drug research and development from "copy-oriented" to "imitation-integrated" strategy.