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Medical news network February 28th 2016, the State Food and Drug Administration on the drug regulatory reform moves frequently: heavy combat counterfeiting and selling illegal drugs and medical devices, review and approval system reform and innovation mechanism, the steady implementation of generic conformance assessment and a series of initiatives, which embodies a "strict". How effective? In February 27th, the State Council held a new conference, the State Food and drug administration secretary Bi Jingquan drying out in the 2016 report card".
Rule of law: Code of practice for naming generic names of Chinese medicines
The name of the drug is a part of the drug standard, but in our country, due to historical reasons, some of the names of Chinese patent drugs have exaggerated and implied efficacy, misleading consumers. For example, a drug called "being", and the name of the drug in clinical medication may mislead some doctors, especially the grassroots doctors.
Bi Jingquan introduced, in order to solve this problem, in 2014 the State Food and drug administration set up a science and technology group, specializing in the study of the characteristics and laws of ancient Chinese medicine nomenclature, and drafted the technical guidelines for the naming of proprietary Chinese medicines. In order to ensure the rigor, the State Food and drug administration also open the guiding principles of proprietary Chinese medicine, solicit opinions from the community.
I Izumi stressed that the focus of the specification of the naming of Chinese medicine is to straighten out the effect of exaggeration, suggesting that the efficacy and vulgar language naming. For the naming of the situation is not standardized, not one size fits all, but will be combined with the standard to improve the registration and other work gradually standardized, really need to modify the name, will give a certain period of time to gradually transition.
Innovation: generic drug consistency evaluation
The consistency of the evaluation of the quality and efficacy of the approved generic drugs, in 2012 January the State Council issued a "12th Five-Year" drug planning tasks, and issued "reiterated on the reform of drug and medical device review and approval system" in 2015 by the state council.
Bi Jingquan introduction, to carry out the purpose of evaluating the consistency of quality and efficacy of generic drugs, is to make the production of generic drugs in China can be replaced with the original research in clinical medicine. Its benefits include reducing the burden of medical expenses, improving the international competitiveness of Chinese pharmaceutical enterprises and promoting the structural reform of the supply side of the pharmaceutical industry.
In fact, the main contradiction of Chinese drug imitation is to solve the problem of "good". Improved new drugs to "excellent", generic drugs to "same"". Therefore, the reform is to make pharmaceutical companies, pharmaceutical industry to the path of innovation.
Bi Sheng said with data that the enthusiasm of enterprises to participate in the evaluation of consistency, at present, the office of generic drug consistency evaluation has received more than 4 thousand applications for the preparation of the reference, the filing of a variety of more than and 700.
The comprehensive needs of the market, regulators still has a long way to go. On the one hand, we should strive to solve the clinical trials enterprise resource shortage, the reference preparation selection difficult problem; on the other hand to do the translation and publishing of all varieties of the consistency of the evaluation guide service work, in conjunction with relevant departments to study and formulate preferential procurement, Medicare reimbursement policies, create a favorable external environment for enterprises to promote consistency the evaluation of the work.
Reduce backlog: drug review deal
August 2015, the State Council issued the opinions on the reform of pharmaceutical medical equipment examination and approval, marking the full start of the reform of drug approval.
Now, the result of the reform in the following aspects: a number of new priority listing, authenticity and reliability of clinical data verification has achieved preliminary results; drug marketing authorization holder system to carry out a pilot in ten provinces and cities; scientific and efficient system of drug and medical device review and approval system preliminary formation; indications, reviewers review team with the review conference communication, the expert advisory committee of a public demonstration to solve the major differences of system have been established; review and approval of drugs have already begun to implement the results to the public; the number of drug evaluation personnel are also expanding, from 120 years ago to the end of 2016 increased to 600; at the same time, the number of applications for registration of the backlog has been composed of 22000 pieces the peak in 2015 dropped to about 8000 now.
Strictness: 2017 food and drug safety supervision work
In order to further stimulate the vitality of the pharmaceutical industry, completed seven aspects of work.
First, to speed up the work of drug quality consistency evaluation. To expand the resources of clinical trials, to explore the methods for evaluating the quality and consistency of injections, and to re evaluate the safety and efficacy of traditional Chinese medicine injections.
Second, encourage drug innovation. Study on encouraging drug innovation policy, improve the drug professional links and data protection system, and to achieve international recognition of clinical data outside the territory, reduce the cost of research and development of enterprises.
Third, the establishment of the review of the leading medical device review and approval technology system. We will continue to increase the technical review personnel and inspectors of pharmaceutical and medical devices, and gradually form a review and approval mechanism based on technical review, on-site inspection and product inspection.
Fourth, the responsibility of the implementation of on-site inspection. To strengthen the on-site inspection of the clinical trials of medical devices and the on-site inspection of the production process, to strengthen the verification of the authenticity of the declaration data, to clarify the legal responsibilities of the inspectors and to supervise the inspection units.
Fifth, the establishment of drug varieties file. For each of the listed drugs, including drug formulation, raw materials, packaging materials, quality standards, brochures, post market security |
