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    Home > Active Ingredient News > Drugs Articles > CFDA pressure: key points of standardizing drug registration and acceptance

    CFDA pressure: key points of standardizing drug registration and acceptance

    • Last Update: 2015-08-06
    • Source: Internet
    • Author: User
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    Source: CFDA 2015-8-6 recently, CFDA intensively issued the notice on further standardizing the acceptance of drug registration on August 5, after soliciting the announcement on accelerating the solution to the backlog of drug registration applications The main idea is very clear: clear up the backlog and standardize the acceptance However, one of the most important ones needs to be noted: "the notice requires all provincial bureaus to strictly abide by the time limit for drug registration and acceptance, indicate the name and responsibility of the handling personnel, and timely correct the problems such as number grabbing and repeated declaration." The notice has improved the handling methods of problems that may be encountered by the Provincial Bureau in the 2007 version of the administrative measures for drug registration For example, after the formal review, it is necessary to "inform the applicant of all the contents that need to be supplemented and corrected at one time, and if the contents still do not meet the requirements after the correction, they will not be accepted"; for the inspection and inspection results, "they shall be submitted to the general administration according to the requirements, and if they are not qualified, they shall be returned to the application materials directly"; it is necessary to list the six categories and 19 aspects involved in the "Supplementary requirements" for each provincial Bureau as the basis for response In addition, the notice emphasizes the responsibilities of the managers of the Provincial Bureau: the managers need to be identified after training and examination; the names of all managers should be indicated; CFDA will check the acceptance of each bureau, and any problems will be investigated According to the industry discussion, this will help to solve the problems such as number grabbing, over time acceptance and so on, which are easy to occur in the materials submitted by the Provincial Bureau In addition, enterprises should also timely correct the problems such as incomplete acceptance materials and inaccurate registration classification Discussion: how does the Provincial Bureau guide rational declaration? Since April 2005, CFDA has formally entrusted "the right to accept drug registration applications to all provincial bureaus", the task of guiding enterprises to apply rationally has been entrusted to the provincial bureaus: Article 50 of the measures for the administration of drug registration revised in [2005.4 notice on regulating drug registration and purifying drug registration environment]:“ The same new drug technology shall not cause different applicants to apply separately or repeatedly in disguised form The State Food and Drug Administration and the Provincial Bureau may, according to the needs of the examination, organize the examination of the relevant situation If the verification is true, it shall not be accepted, and if it has been accepted, it shall be withdrawn from the trial " The applicant shall be highly wary of multiple sales and other non-standard behaviors when selling drug technology for registration application In the "acceptance of drug registration" column of drug registration varieties query on the website of our bureau, the latest information of acceptance quantity of the same variety can be inquired at any time [2014.9 announcement on the publication of the catalogue of the first batch of excessively repetitive drug varieties (2014 No.45)] the food and drug administration departments of all provinces, autonomous regions and municipalities directly under the central government shall strengthen the acceptance examination, development site inspection and production site inspection of relevant drug registration applications, and do a good job in publicity and guidance of the announced excessively repetitive drug varieties Now, this requirement is mentioned again: Article 7 of [2015.7 notice on further regulating the acceptance of drug registration]: in order to further guide the application and acceptance of drug registration, the General Administration will continue to issue the announcement of over repeated varieties, and the provincial bureaus shall guide enterprises to apply rationally For example, according to the 2015 annual drug review report, solving the problem of drug registration backlog is helpful: by the end of 2014, there were 3983 chemical validation clinical applications to be reviewed, accounting for 21.4% of the total tasks to be reviewed, involving 675 active ingredients There are 42 active ingredients (more than 20 tasks of the same active ingredient variety to be reviewed) that have been repeatedly declared seriously, involving 1608 tasks to be reviewed, accounting for 40.4% of the total tasks of chemical validation clinical to be reviewed Among them, more than 50 active ingredients of the same active ingredient variety are: azilsartan, rofluoristone, ibuprofen (injection), and lulasidone However, as a single node of collecting and accepting drug registration information, the provincial bureau is unable to understand the application of the same product in multiple places; the catalogue of repeated application issued by CFDA is a sort of past information and cannot provide guidance for the prevention of repeated application; there is considerable operation space for the provincial Bureau to determine and reject the varieties of repeated application How should the sentence "guiding declaration" be implemented?
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