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    Home > Active Ingredient News > Drugs Articles > Latest progress of self inspection: 5 products have been approved in the on-site inspection catalog!

    Latest progress of self inspection: 5 products have been approved in the on-site inspection catalog!

    • Last Update: 2016-10-25
    • Source: Internet
    • Author: User
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    Source: medical economics Daily, October 22, 2016, the on-site verification plan for clinical trial data of drugs No 7 was released In less than seven months, from March 30, 2016, No 1 to October 22, 2016, No 7, a total of 185 acceptance numbers are involved in the seven batch verification plan The author conducted in-depth analysis on the 185 varieties of these 7 batches corresponding to the first batch of self-examination varieties (1622 announced on July 22, 2015), the second batch of self-examination varieties (181 announced on April 1, 2016) and the third batch of self-examination varieties (82 announced on September 1, 2016) In the past three months, the first batch of self inspection and no manufacturer withdrew the notice on self inspection and verification of drug clinical trial data issued by CFDA on July 22, 2015, which requires the applicant to conduct self inspection on the authenticity, integrity and standardization of 1622 registration applications for listing and import, that is, "the first batch of self inspection" clinical trial data For the 1622 varieties in the first batch of self-examination, 193 of which are exempt from clinical trials are deducted, and 1429 varieties need self-examination According to the data of "director of the pharmaceutical registration department of the food and Drug Administration talks about clinical data verification of new drugs", by the end of June 2016, 1193 enterprises had voluntarily applied for withdrawal through self inspection, accounting for 83% of the total number of self inspection Compared with the historical announcement of CFDA, Xianda data V3.2 found that there were 317 actively withdrawn registration applications in the 169th announcement on August 28, 2015; as of the forty-fifth announcement on March 1, 2016, which was the latest announcement withdrawn, there were 876 actively withdrawn registration applications, just 1193, consistent with the number withdrawn at the end of June This means that there has been no active withdrawal of drugs for three consecutive months since the last withdrawal announcement This means that the withdrawal of the enterprise has basically been finalized, so CFDA food and drug audit and inspection center will carry out the on-site verification plan of clinical drug test data from March 30 Details of the original text: http://
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