Medical news network February 10th issued "on the day before the State Council opinions on further reform and improve the drug production and circulation use policy". Health care reform office of the State Council, the relevant person in charge on the question, answered a reporter's question.
In view of the problem of the high price of some drugs, this paper puts forward the omni-directional measures
Q: what are the policy highlights? What benefits will be brought to the masses?
Answer: the outstanding problems in current drug quality, drug prices artificially high and uneven part of the masses, the "opinions" to the problem oriented, from the use of the whole process of production and circulation of the whole chain, puts forward a series of reform initiatives aimed at. The main policy highlights are:
To speed up the examination and approval of new drugs and the shortage of drugs. Learn from international advanced experience, explore the rare disease, children, the elderly, emergency medicine and traditional Chinese medicine (Classic) and other categories of examination and approval.
The generic drugs, which are evaluated by consistency of quality and efficacy, are included in the list of alternatives to the original drug. With the variety of drugs through the consistency evaluation of the production enterprises reached more than 3, in the centralized drug procurement and other aspects of the consistency evaluation no longer used varieties; no more than 3, also should give priority to the purchase and has been used by the consistency evaluation of varieties.
The patent medicine and patent has been the exclusive production of drugs, drug prices, commitment to take registration negotiation, centralized purchasing, Medicare payment and other comprehensive measures to promote the implementation of China's listed in the sales price is not higher than the country of origin or China's neighboring comparable price, and the implementation of dynamic management.
To strengthen the management of medical representatives, the establishment of medical representative registration system. Pharmaceutical representatives can only engage in academic promotion, technical advice and other activities, shall not assume the task of drug sales, dishonesty credited to the personal credit record.
The implementation of the opinions will bring tangible benefits to the masses. First, the quality of drugs will be more secure. Second, to further reduce the high price of drugs, reduce the burden of medical expenses. Third, improve drug supply support capabilities, so that people more convenient and quick medication. Fourth, the public hospital break in yaobu mechanisms, promote more standardized and rational drug use.
To carry out the consistency evaluation of generic drugs, so as to make the quality and efficacy consistent with the original drug
Q: why should we promote the quality of generic drugs and the consistency of efficacy evaluation? What is the support policy for a one-time evaluation of the drug?
A: the evaluation of the quality and efficacy of generic drugs is a practical work. The consistency of the evaluation of generic drugs that have been approved for listing is a lesson in history. Because in the past we have not approved the listing of drugs with the original drug consistency of the mandatory requirements, so some drugs in the efficacy of the original research and there are some gaps.
Historically, the United States, Japan and other countries have also experienced the same process, Japan spent more than a decade to promote this work. To carry out the consistency evaluation of generic drugs, can make the generic drugs in the quality and efficacy of the same as the original drug, in the clinical alternative to the original drug. This can not only save medical costs, but also can improve the quality of China's generic drugs and the pharmaceutical industry as a whole, to ensure the safety and effectiveness of public medication. This is good in our country, but also innovation.
Consistency evaluation is a kind of work that requires the enterprise to invest capital, technology and time to solve the problems of quality, process improvement and technology upgrading. Through the consistency of the evaluation of drug varieties, by the State Food and Drug Administration announced to the public, drug manufacturers can be marked in the drug instructions, labels. Medical institutions will give priority to procurement and priority in clinical. Accelerate the development of medical insurance payment standards in accordance with the generic name, as soon as possible to facilitate the formation of an incentive mechanism for the use of generic drugs through consistency evaluation.
Pilot drug licensing system to mobilize the enthusiasm of R & D personnel
Q: what is the system of drug listing holders? What is the significance of this system?
A: the system of drug listing holders is a common practice in the field of drug regulation in developed countries and regions, such as Europe, the United States and japan. The system uses drug license and production license separation management mode, allowing the drug license holders (drug manufacturers, research institutions or scientific researchers) to produce drugs, or any other drug production enterprise.
At present, the domestic drugs, China only allows the drug production enterprises in obtaining drug approval, the GMP certification, can produce the drug. In practice, pharmaceutical research institutions and researchers to get drug approval number, new drug R & D institutions received certificates of new drugs after only related to drug technology transfer to pharmaceutical production enterprises. This drug registration and production license binding mode is not conducive to encouraging innovation, is not conducive to the protection of drug supply, is not conducive to the suppression of low-level redundant construction.
To carry out drug marketing authorization holder pilot system, is an important content of the reform of drug approval system, is conducive to drug research institutions and researchers actively create new drugs, is conducive to the adjustment of industrial structure and optimize the allocation of resources, reduce duplication of investment and construction, conducive to the promotion of professional division of labor, improve industrial concentration.
Coordinate the promotion of fixed-point shortage of drugs, expand the scope of fixed-point production
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