CFDA Regulates Medical Enterprises More Hardly

Clinical trials of self-examination, verification and anxiety in the industry questioned vigorously promote and usher in the climax of the withdrawal of drug registration, as of March 1, 2016, document number 1622 in the 1171 Drug application for registration has been withdrawn by the applicant registration, accounting 72.2% of the total number of self-examination, another 24 drug registration application CFDA disapproval, accounting for 1.5% of the total self-examination.

On March 28, 2016, CFDA promulgated the “drug clinical trial data verification procedures (provisional)”, self-examination and clinical trials into the normalization. April 29, 2016, CFDA publish the results of the third round of review, there are seven companies six drug applications not approved registration, no CRO enterprises to enter the list. Three down and review, a total of 30 pharmaceutical companies to apply for registration 29 products for various reasons will not be approved.

Event Comments: This is a crisis for the CRO business, it is a challenge and an opportunity. As medical research Haitong think, CRO industry is in the worst of times, it was the best of times. Clinical trials of self-examination in 2016 will gradually normalized, and the resulting short-term clinical trials institutions underpowered, but with the gradual elimination of the impact, with the resource advantages of clinical trials Clinical CRO companies will benefit from the recovery priority growth industry.

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