Medical news network February 28th February 27th at 10 in the morning, the State Council Information Office held a press conference, the State Council director of food safety office, director of the State Food and Drug Administration Bi Jingquan introduced food and drug safety supervision in China, and a reporter asked.
The meeting, Bloomberg News Agency reporters: 2017 drug review what the new policy will bring great impact on multinational pharmaceutical companies in Chinese what market access?
Bi Sheng said that the reform of the medical device examination and approval system, which is the task of the Communist Party of China in the third Plenary Session of the 18th CPC Central Committee to deploy reforms. In August 2015, the State Council issued the opinions on the reform of the medical equipment examination and approval, marking the full start of reform. This reform is mainly around the improvement of quality, solve the backlog, optimize the service of three objectives.
For more than a year, the curative effect of generics quality consistency evaluation work in full swing, a number of new priority listing, authenticity and reliability of clinical data verification has achieved preliminary results, drug marketing authorization holder system carried out in ten pilot provinces and cities, scientific and efficient system of drug and medical device review and approval system preliminary formation, adaptation in the review, review and review team member 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 has begun the implementation of the results to the public.
The number of people working for drug reviewers increased from 120 people two years ago to the end of last year to more than 600. The number of applications for registration of the backlog has been from 22000 at its peak in 2015 dropped to about 8000 now.
In the new year, we must continue to deepen the reform of medical device medical examination and approval system reform, a comprehensive solution to the backlog of contradictions, and further stimulate the vitality of the pharmaceutical industry, there are seven key areas of work:
First, to speed up the work of drug quality consistency evaluation. Because, in the China generics on the market or clinical subject, we should expand the clinical trial resources, quality and efficacy of injection method to explore the consistency of evaluation, and evaluation to start the safety and effectiveness of drugs of traditional Chinese medicine injections.
Second, encourage drug innovation. We should encourage research in pharmaceutical 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, to establish a technical system of drug and medical device approval review leading, we should continue to increase drug medical devices evaluation personnel and inspection personnel, and gradually form a technical evaluation as the core, on-site inspection and inspection of products for the evaluation of technical support and approval mechanism.
Fourth, the responsibility of the implementation of on-site inspection. It is necessary to strengthen the on-site inspection of the clinical trial of medical equipment and the on-site inspection of the production process, to strengthen the verification of the authenticity of the data, to clarify the legal responsibility of the inspectors and the supervision responsibility of the inspection units.
Fifth, the establishment of drug varieties file. We need to build up a database for each of the listed drugs, including drug prescriptions, raw materials, packaging materials, quality standards, specifications, post marketing safety information, production process changes and other information. Because of the history of the approval of the drug, the requirements of different ages are not the same, so some of these files are missing, and some enterprises to adjust the process of adjustment is not timely approval or filing.
Sixth, to establish the drug electronic common technical document system (eCTD system), to the end of this year can be achieved according to the new system to implement electronic filing and review, so that it can reduce enterprises, especially in the overseas enterprises to declare to declare China requirements basically is a kind of format is the same, reduce the burden on us.
Seventh, to speed up the process check. Pharmaceutical production enterprises must be in accordance with the national approval of the production process, the process of verification of the views, we are in accordance with the recommendations of various aspects of the revised and improved, as soon as possible to issue.
Beijing News reporter asked: in 2015, China began the consistency evaluation of generics for this work, people may still not understand, want to please Bi TA to introduce it to the people to bring benefits, as well as its objectives and are now in the process of. Because now many people worry that the task is so heavy, can be completed on schedule? Finally, there are a lot of people questioned, to carry out the consistency of generic drug evaluation does not mean that the quality of the drug problems?
Bi Jingquan said, the consistency of the evaluation of the quality and efficacy of the approved generic drugs, this is the 2012 January the State Council issued the "12th Five-Year proposed" drug planning tasks, in 2015 the State Council issued the "on the reform of drug and medical device review and approval system" reiterated this request, so this work is not new carry out. In the past, we have not approved the listing of drugs and the quality of the original study of the efficacy of the consistency of the requirements, not mandatory requirements, so there are some drugs on the efficacy of the original drug and there is a gap. The purpose of the evaluation of the consistency of the quality and efficacy of generic drugs is to make our production of generic drugs in clinical practice and the original drug alternative. The advantage is that it can reduce the burden of medical expenses and improve the international competitiveness of Chinese pharmaceutical enterprises.
The quality of drugs in China to look at the history of the development of view, in accordance with today's standards to see more than a decade ago, a few decades ago approved the listing of drugs |
