Since the formal implementation of the new ‘Drug Registration Regulations’, Chinese Drug Registry encourages more on innovations, the current proportion of new drug submission is increased significantly to 40%, comparing to less 20% few years ago. The effect of innovation stimulation began to reveal.
Deputy general director of SFDA, Mr. Wu Zhen spoke at National Drug Registration Management Work Conference held in Wuhan on 4th, that since the implementation of the new ‘Drug Registration Regulations’ on Oct, 1st, 2007, problems like the duplicated submission had been obviously reduced, the registration receival had also reduced dramatically, however, the proportion of new drug submission increased significantly, which indicates that enterprises put more attention on the R&D and registry of the new drugs.
According to statistics, from Oct, 2007 to the end of 2009, SFDA had received 4444 cases of drug registration, the total annual volume decreased by more than 2/3. Among which, 1786 cases were new drug submissions, with a proportion of 40.2%, which increased significantly comparing to last year. Meanwhile, due to the strictness of legal evaluation process, the number of approved ones decreased dramatically to 739 cases in 2009, comparing to more than 10,000 in 2006.
Mr. Wu said, at present, the overall level of Chinese R&D on medicine is not high, therefore, the pharmaceutical regulatory departments must carry out their guiding duties, encourage innovation, lead innovation, support innovation, service innovation, and lead the enterprises to the R&D of new products.
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