10 years' sacrifice of 2006 drug registration and verification Massacre

Today is the first anniversary of the 7.22 clinical trial verification There are many articles reviewing and reflecting on this year Today, let's go further and look back to 10 years ago to see how the registration verification was conducted before 2006, and the history may be repeated, so it's more worthy of our reference, especially for those who entered the industry later, and need to understand that history At that time, the author was also one of the leaders of many R & D forces Many R & D companies declared their products in a hurry (not using the wrong words, compared with the current R & D speed, the description is more accurate) The more I heard that the State Food and Drug Administration wanted to register and close the door (for example, the change of drugs and the imitation of traditional Chinese medicine could not be reported), the more the boss let us speed up the progress until one day The wolf is coming! I'm not afraid Didn't wolves just hang around us before? This time, the wolf is really moving He starts to eat sheep The action of 10 years ago is similar to that of last year's 7.22 Can you see the 2006 notice on Further Strengthening the on-site inspection of drug registration attached to the document? Is it familiar? The difference is that in 2006, clinical trials and preclinical trials were comprehensively verified On July 22, only clinical trials were verified, and repeated mobilization / bluffing was carried out First, self-examination and self correction were carried out, so that most of the declared varieties were removed by the enterprise, then centralized review was started, and detailed technical requirements for review were formulated Each technical requirement is a life-threatening requirement not approved However, enterprises also make every effort to prove that the previous information is "true" through more sophisticated fraud At that time, there was a rumor that before the registration and inspection, the drug R & D personnel were liars (serious fraud), the drug reviewers were fools (no matter whether they were good or bad), the reviewers during the inspection were lunatics (basically one was shot for the declared varieties), and the drug R & D personnel became idiots (gaped at a pile of shot products) Phoenix bath fire can only be called Phoenix if it can't be reborn If it can't be reborn, it is dead (bird) The registration verification started in 2006 has brought down a large number of varieties and a number of R & D enterprises With the introduction of new drug registration management measures in 2007, the R & D industry in China has gradually become standardized However, in the social environment of dishonesty, in the slack of the regulatory authorities, driven by the interests of enterprises, and after the high pressure of verification, some enterprises began to make false (irregular) actions, especially in the most critical and most expensive clinical trials, so there was the 7.22 clinical trial verification tragedy last year Qin people have no time to mourn for themselves, but later generations mourn for it; later generations mourn for it without learning from it, which also makes later generations mourn for it again After the registration verification 10 years ago, drug R & D has been standardized and improved a lot, but it is not thorough Last year's 7.22 verification was very thorough I hope that today's drug R & D industry can learn from the lessons of "blood" and stick to them After 10 years, there is no need for another centralized verification of drug registration Attachment: Notice on Further Strengthening the on-site inspection of drug registration (gsyjz [2006] No 265) of food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration): The on-site verification of drug registration is an important part of drug registration review In order to strengthen drug registration management, standardize drug registration application behavior, ensure that drug review and approval are based on authenticity, reliability, objectivity and fairness, and ensure drug safety, effectiveness and quality control from the source, in accordance with the spirit of the national special working conference on drug registration management, the State Administration On the basis of soliciting the opinions of relevant provincial bureaus, relevant measures for further strengthening the on-site inspection of drug registration have been studied and formulated, as follows: 1、 Since June 2006, all provincial bureaus have organized drug registration applicants within their jurisdiction according to the list provided by the State Administration (with CD-ROM attached), carried out self-examination and self correction for drug registration applications submitted to the State Administration, and verified and confirmed the authenticity and integrity of application materials Any application for registration found to be in violation of regulations shall be withdrawn immediately Before August 31, all provincial bureaus shall submit the feedback form of special inspection results of drug registration (withdrawal application) (see Annex 1) to the drug registration department of the State Administration by stages and in batches to the drug evaluation center of the State Administration If there is no problem with the registration application, the feedback form of special verification results of drug registration (confirmation application) (see Annex 2) can be submitted to the drug registration department of the State Administration by stages and in batches by the enterprise before August 31, with a copy to the drug evaluation center of the state administration, and the self inspection report form (see Annex 3) can be submitted to the drug registration department of the State Administration before August 31 2、 The National Bureau and the provincial bureaus will organize an expert group to conduct spot check on the registration applications that are confirmed to be free of problems through self inspection and self correction by drug registration applicants If any fraud is found, it will be severely investigated and punished according to law, recorded in the bad records, and published to the public 3、 Starting from June 2006, all provincial bureaus shall, in strict accordance with the provisions of the procedures and requirements for on site inspection and sampling of drug registration (Trial Implementation), comprehensively and carefully check the registration applications that have been accepted but not yet submitted to the drug evaluation center of the State Administration item by item If any item is found to be inconsistent in the inspection without reasonable explanation, it shall be deemed as "inconsistent" in the inspection conclusion, and the applicant shall be required to withdraw his registration application 4、 From June 2006, when the provincial bureaus carry out on-site verification of newly accepted registration applications, in addition to strictly implementing the procedures and requirements for on-site verification and sampling of drug registration (Trial), they must also check and record the following elements and links （1） The purchase and use of chemical APIs or traditional Chinese medicine raw materials under the control of drug approval number shall be further checked For the purchase of domestic chemical APIs, the original supply agreement and sales invoice signed directly with the legitimate API manufacturer shall be checked; for the purchase of imported APIs, the original supply agreement signed directly with the foreign API manufacturer or with the domestic import sales agent authorized by the foreign enterprise shall be checked For the raw materials of traditional Chinese medicine such as APIs, extracts and medicinal materials used in traditional Chinese medicine preparations, it shall also check whether the drug approval number management has been implemented For the purchase of raw materials of traditional Chinese medicine under the management of approval number, the original supply agreement and sales invoice signed directly with the raw material manufacturer with approval number shall be checked For the purchase quantity of the above-mentioned chemical APIs and raw materials of traditional Chinese medicine, it is necessary to check whether they meet the needs of the research, sample reagents, etc carried out （2） For trial production and research records, the original records and original atlas shall be checked （3） For the instruments and equipment involved in the research, their configuration, operation status and use registration shall be checked （4） If the research work involves experimental animals, the management of experimental animals shall be checked in accordance with relevant regulations （5） When applying for registration of a new drug, if the approval number is applied for or the national standard drug is applied for registration, it shall be checked whether the sample trial production is completed on the actual equipment used for mass production by the manufacturer, whether the sample trial production volume is compatible with the actual batch production capacity of the variety after verification, and whether the trial production volume of three batches of samples is respectively the maximum verified production capacity of the variety , half quantity, minimum quantity （6） The time connection point of the whole process of drug research shall be checked, for example, whether the time difference of relevant experiments of process research and quality stability research is reasonable Appendix: 1 Feedback form of special verification results of drug registration of the Provincial Bureau (withdrawal of application) 2 Feedback form of special verification results of drug registration of the Provincial Bureau (confirmation of application) 3 Original statement of the State Food and Drug Administration on June 16, 2000: This is the original manuscript of yaozhi.com, welcome to reprint, please indicate the source and author of reprint, thank you!