CFDA asked for opinions overnight: consistency evaluation policy brought about a big earthquake in the pharmaceutical industry!

Source: Pharmaceutical cloud information 2015-11-19 CFDA has been very busy recently The reform of the drug review system, the solution to the squeeze of application approval documents, the processing of clinical data fraud, and the evaluation of the quality consistency of generic drugs are all large projects Their importance and busy degree are no less than the centralized procurement of national drugs in the health and family planning system On November 18, the opinions on the consistency evaluation of quality and efficacy of generic drugs (Draft for comments) were released overnight The draft was heavily worded and reiterated the time limit for completion I wish I could use a whip to finish it It is stipulated that the consistency evaluation of the base drug oral solid preparation approved before October 1, 2007 shall be completed before 2018 If it fails to pass the evaluation at that time, the approval number of the drug shall be cancelled For other generic drugs approved for marketing before 2007 and those approved for marketing after 2007, if the same product of other manufacturing enterprises fails to pass the evaluation within 3 years after the first product passes the consistency evaluation, the approval number of the drug shall be cancelled If this series of requirements are really implemented, it can almost be predicted that in the next few years, the approval documents of domestic pharmaceutical enterprises will be cancelled in a large area, and the corpses will be everywhere In the past 20 years, I have hardly seen the collapse and bankruptcy of drug manufacturing enterprises, but only the merger, reorganization and restructuring Among them, due to the scarcity of drug approvals, they have played a role in the survival of drug enterprises, so it's impossible to change hands and resell them But in the future, the consistency evaluation of generic drugs is a sword of Damocles Whether the approval is valuable and whether it can pass the consistency evaluation becomes a necessary prerequisite Of course, while wielding a big stick, CFDA also uses carrots to guide pharmaceutical companies forward according to the prescribed schedule and roadmap For the products that pass the consistency evaluation, the social security department shall give appropriate support in the aspect of medical insurance payment, the medical institutions shall give priority to purchasing and selecting in clinical practice, and if more than three products of the same type pass the consistency evaluation, the products that fail to pass the evaluation shall not be selected in the aspect of centralized purchasing According to diancanghe, CFDA hopes that the human resources and social security department will formulate relevant medical insurance payment standards to distinguish the drugs that pass the consistency evaluation from other generic drugs that fail, and encourage clinical priority use If it can be implemented, it will change the pattern of drug use, which will have a great impact on the original research drugs and other generic drugs In addition, in the centralized procurement of drugs, from the classified procurement spirit of Document No 7 to the implementation of procurement programs in all provinces and cities, it is clear that the varieties through the consistency evaluation of generic drugs will be listed and grouped separately If more than three varieties of the same variety pass the consistency evaluation, the failed varieties will not be selected This will further strengthen the dominant position of these varieties and block other varieties from the market access link These three positive incentives encourage the overall acceleration of consistency evaluation In order to finish in the deadline or be the first three to pass the consistency evaluation, pharmaceutical enterprises are racing with time and competitors It's a race between life and death, a contest with one's peers The design of the draft really took some effort But at the same time, we should also see that the above three items are related to the access, purchase, use and reimbursement of drugs, which are proposed by the drug administration and span the human resources and social security department and the health department I don't know whether the other two ministries will buy the bill or not See the original link of the draft for comments: http://