Is the withdrawal product dead in 72 cases or in centralized review?

Source: the centralized review of Xinkangjie / Bai Xiaokong on September 2, 2015 is said to have started in August, and 72 products in the frontier have been said to be very injured How to distinguish between 72 deaths or centralized review? First of all, Article 72 comes from Article 72 of the measures for the administration of drug registration (Order No 28 of the board)“ After the application for registration of imported drugs is first approved, if the domestic applicant has been approved for clinical trials, the application may be continued in accordance with the drug registration application and approval procedures If the application meets the requirements, the State Food and drug administration shall approve the application for production; the applicant may also withdraw the application and make a new application for generic drugs The applicant may apply for generic drugs if other applications of the same variety that have been accepted but have not been approved for clinical trials of drugs are returned And the centralized review comes from Article 6 of the announcement of the State Food and Drug Administration on seeking some policy opinions on accelerating the solution of the backlog of drug registration applications (No 140, 2015), "the backlog of the same varieties shall be subject to the centralized review For the same varieties that have been accepted, the centralized evaluation shall be organized according to the unified evaluation standard and scale In case of non-compliance, the decision of disapproval shall be made in a timely manner; in case of compliance, the decision of examination and approval shall be made in the order of application and the approval certificate shall be prepared and issued " To sum up, it can be preliminarily judged that the corresponding imported product of the product is on the market, and before the approval of the imported drug, the product was withdrawn from the trial because it did not obtain the clinical approval document, and in all likelihood, 72 articles died In addition, Article 66 of the measures for the administration of drug registration focuses on the technical monitoring system established for the production of new drugs approved for the first time by domestic drug manufacturers "The State Food and drug administration may establish a monitoring period for new drug varieties approved for production in accordance with the requirements for the protection of public health The monitoring period shall be calculated from the date of approval of new drug production, and shall not exceed 5 years at most The State Food and drug administration shall not approve other enterprises to produce, change dosage forms and import new drugs during the monitoring period " There are also 71 supporting articles: "from the date when the new drug enters the monitoring period, no more applications for registration of the same variety from other applicants will be accepted." Other applicants who have accepted but have not yet approved the clinical trial of drugs shall be returned with the application of the same variety; after the expiration of the new drug monitoring period, the applicant may apply for generic drugs or imported drugs " Through Xianda data v3.2, the author screened many chemical drug products with "certificate preparation completed" and "approval completed" from June 2015 to now The results are as follows: Hengrui pharmaceutical industry is the domestic listed manufacturer with the most benefits in recent monitoring period due to 66 and 71 protections enjoyed by non Brescia and non Brescia tablets In the past three months, there are nine listed companies that are affected by 66, 71 or 72 articles and face the risk of withdrawal of registered products, namely, Haizheng pharmaceutical, Kangyuan pharmaceutical, Fosun Pharmaceutical, Lukang Pharmaceutical, Kelun pharmaceutical, Laimei pharmaceutical, Hengrui pharmaceutical, Sinopharm, Fu'an pharmaceutical, and one new third board is Xinghao pharmaceutical For the time being, China pharmaceutical, Fangsheng pharmaceutical and Fuan pharmaceutical industry have benefited from the accelerated clinical evaluation Summary: the review and approval of drug registration is speeding up, or the growth rate is not obvious from the number of acceptance numbers of "certificate preparation completed" or "approval completed" every month in the past five months, but there are more and more products that are returned for review in accordance with the drug registration management measures Even if the clinical approval speed of products temporarily exceeds that of foreign enterprises, there will still be consistency evaluation ahead of the generic manufacturers in the future In the short term, it makes sense that the world's martial arts are only fast It's better that the clinical approval time is earlier than the first approved production time, but isn't the first listed enterprise better?