From the data disclosed recently by Mr.Shao Mingli, director of State Food and Drug Administration (SFDA), it has shown that, in year 2009, China had received 3357 applications for drug registration, comparing to 2 years ago with thousands of applications per year, there’s significant change. However, among which, during Jan and Jun, 2009, SFDA approved 173 new drug clinical applications and 238 new drug production applications, comparing to 26 cases approved by US FDA in 2009, there’s still gaps in the degree of strictness of the control.
Mr.Shao Mingli pointed out that, in the past, the new drug was just the old drug with slight alteration or addition, the problem of ‘new drug is not new’ has raised great concerns. Within these 2 years, SFDA has fully implemented the newly edited Drug Registration Regulations, which elevates the registration approval threshold, reduces duplications of submissions with low quality. Among the 3357 registration applications submitted in 2009, the ratio of new drug application has reached 35%, the quantity and configuration of the submission have maintained at an appropriate level in 2 years successively.
Meanwhile, besides the strict control of drug approval, reinforce the post market safety supervision of the drugs would ensure the medication safety. SFDA pointed out that, the safety reassessment of drugs with high risk was proposed last year, the injections would be the starting point. Guangdong Provincial FDA initiated the process by reassessing 6 TCM injection solution including Shen qi fu zheng, Shen mai, Xiang-dan, etc., produced by LiZhu Groups, SanJiu Ya-an and Baiyunshan Ming Xing, etc. It has been told that, under the supervision of post market of drug, US FDA requested 31 post market products to be relabeled or added with warning information.
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