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Revised Provisions for Drug Registration at SFDA, PRC
The revised Provisions for Drug Registration was passed by the State Food and Drug Administration (SFDA) at the administration affairs meeting on June 18, 2007, and was promulgated by SFDA commissioner Shao Mingli as SFDA Order No. 28 on July 10,2007. The revised Provisions will go into effect as of October 1, 2007.
The revision adheres to guiding drug registration with scientific regulatory concept, integrating drug registration regulatory resources, deepening the reform on drug registration mechanism, being strict with drug registration procedure to establish an efficient and scientific based drug registration management mechanism.
SFDA Order No. 28 comprises 15 chapters, 177 articles (before revised it was 16 chapters, 211 articles). Key contents modified involve the following three aspects: 1) be strict with drug safety requirements and marketing permission; 2) integrate supervision resources, specify duties and responsibilities, and intensify power restriction mechanism; 3) upgrade the review and approval standards, encourage innovation and restrict low-level repetition.
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