CFDA starts the cleaning of drug number!

Source: Cypress blue, September 21, 2015, the 12th China ASEAN Expo opened in Nanning International Convention and Exhibition Center, Guangxi Province on September 18 Through this meeting, several officials of CFDA released the latest information about the recent focus of the industry, "drug review reform" The above content has spread in many wechat circles and friend circles, and many of them are closely related to the product registration and R & D of pharmaceutical enterprises Among them, the relevant content related to drug approval number and drug sales deserves the attention of enterprises A batch of drug approval numbers will be put forward at the cancellation meeting According to statistics, at present, there are 167000 approval numbers in China, of which 63% are chemical drugs, 36% are traditional Chinese medicine and 1% are biological drugs; 4200 are imported approval numbers, of which 87% are chemical drugs, 2% are traditional Chinese medicine and 449 are biological products If the approval number (import product registration certificate, medical product registration certificate) is not listed within the validity period, and cannot fulfill the responsibility of continuous inspection on drug quality, efficacy and adverse reactions, it shall not be re registered, and shall be cancelled after the expiration of the approval number Current stage (2015-2018): complete the oral solid preparation of chemical generic drugs in the national essential drug catalogue approved before October 1, 2007 According to the statistics of the Chinese Academy of inspection, there are 300 varieties mentioned above, involving 17897 approval numbers and 1883 pharmaceutical manufacturers In fact, we can also see the policy trend of the National Bureau from a notice in the first half of this year On July 16, the State Food and Drug Administration issued the announcement on canceling the approval documents of 76 drugs such as Cloxacillin Sodium for injection Before that, drug re registration was generally a process, and there were few cases that failed to pass re registration In this announcement, according to the statistics of Cyprian, 34 of them The reason for the number of drug approval documents is that the validity period of drug approval documents has expired and they have not been re registered, accounting for nearly 50% of the cancellation In the interpretation of this announcement, cypress blue thinks that there may be more products that can not be re registered through drugs in the future, and the four strictest and most "rigorous" standards have been reflected again This time, the National Bureau has made clear the criteria for failing to pass the registration: the drug is not listed within the validity period and cannot fulfill the responsibility of continuous inspection of drug quality, efficacy and adverse reactions From this point of view, one is that the approval number of drug hoarding is useless Many drug companies used to hoard the approval number of low-cost drugs Now they should transfer it as soon as it can be transferred within the period of validity Secondly, many traditional Chinese medicines with unclear adverse reactions and the approval number of drugs repeatedly notified due to drug quality are dangerous When the generic drug consistency evaluation will kill some varieties of dandelion WeChat official account, when talking about the consistency evaluation, the deputy director of the Central Inspection Institute and the party secretary Li Bo introduced the consistency evaluation of generic drugs, indicating that the quality and efficacy will not be consistent in the future, and will be evaluated in stages and batches It is expected to take 10-15 years Enterprises are encouraged to evaluate varieties outside the catalogue By 2018, those varieties of chemical generic oral solid preparations in the national essential drug catalog that have not passed the evaluation shall not be listed Other varieties, which fail to pass the evaluation within three years after passing the evaluation, shall not be listed If more than three of the same varieties have passed the consistency evaluation, the varieties that have not passed the evaluation will not be used in bidding procurement, medical insurance reimbursement and other aspects Drug sales is the foundation of the survival of enterprises, which are no longer used in listing, bidding procurement, medical insurance reimbursement and other aspects, which simply cut off the lifeblood of enterprises The manufacturers of base drugs should act as soon as possible.