Wu Zhen: the latest interpretation of the new policy on the consistency evaluation of MAH and generic drugs at the publicity and Implementation Conference

Source: Dandelion 2016-07-15 on July 14, 2016, the State Food and Drug Administration organized and held the "national drug listing license holder system pilot and generic drug consistency evaluation publicity and implementation meeting" in Xiamen, Fujian Province, attended by the leaders of the State Administration, the leaders of drug supervision in ten pilot provinces and cities, and 75 enterprises in ten provinces and cities State Council 44 Document No.: after the introduction of the opinions on the reform of the review and approval system of pharmaceutical and medical devices, the State Food and Drug Administration issued a series of policies After the new policies were introduced frequently, the next step is to implement them In this series of new policies, two of the most important policies are: the consistency evaluation of pharmaceutical products, the holding system of drug listing licensors, one is to solve the stock problem, the other is to solve the stock problem It's about solving incremental problems 1、 Drug marketing license holder system: With the development of society, scientific research activities are becoming more and more active, and the forms of drug researchers are diversified According to the previous drug management law, drug holders can only be manufacturing enterprises Therefore, every drug reviewed is accompanied by the purchase of bricks, tiles and equipment, resulting in repeated construction of the bottom level, serious overcapacity, and serious obstacles to drug research and innovation Therefore, it is true that It is imperative to hold the system of drug application listing license The system of listing license is not innovative in China It has been implemented in European and American countries for a long time It is a mature and feasible system in European and American countries Pilot program of drug listing license holder system: 1) what to try: legal relationship, responsibility, drug traceability, etc among all subjects in the holding process; 2) pilot area: ten provinces; 3) strict time limit: three years results; 4) pilot subject: drug production and research enterprises and drug researchers Through the experiment, some experiences were explored and the drug administration law was revised 2、 Generic drug consistency evaluation: generic drug consistency evaluation is not only to solve the problem of drug quality and efficacy, but also to solve the problem of drug stock At present, there are more than 180000 drug approvals, while there are only more than 40000 in the market The other is the current popular saying: Zombie approval For these approval documents of zombies, they are revoked Pharmaceutical companies are unwilling to and will not revoke them One day, enterprises suddenly think of it, and they want to resume production There is a risk Due to the original historical conditions, most of the zombie approval research is of low quality, and the research is not compared with the original research, so the quality is not guaranteed Consensus re evaluation is a common practice in the world At present, it has been widely concerned At the same time, many people are confused and anxious about it Some people say that the General Administration will eliminate how many approvals and how many enterprises It is clear here that the general administration does not have any requirements for elimination instructions How much to eliminate depends on market behavior The consistency evaluation is divided into two parts: consistent dissolution in vitro and consistent absorption in vivo Some products are highly related in vitro and in vivo and can be exempted; most products also need to be bioequivalence of human body It's said that it costs money to do be and get on the human body It's said that it costs 3 million and 5 million to do a pre test and formal be now The price is indeed too high, but this is also an inevitable phenomenon in the development process The price of 100000 and 200000 before was also too outrageous We are also working on how to open up research institutions And the purchase of reference preparations and so on, we are all solving step by step Wechat we are also following, but we have been diving Therefore, face-to-face publicity and implementation, strengthen communication, reduce misreading and misleading, is the purpose of this publicity and implementation