2019-05-29
 Bi Jingquan introduction, the reform of medical equipment examination and approval system, is the 18th Plenary Session of the Communist Party of China to deploy the reform task. August 2015, the State Council issued a "review of drug medical equipment on the review and approval of the views", marking the reform of the full start. Over the past year, the quality of generic drug efficacy evaluation work in full swing, a group of new drugs priority to be listed, the authenticity of clinical data, reliability verification has also achieved initial results, drug listing license system in ten Provinces and cities to carry out pilot, scientific and efficient drug medical equipment examination and approval system for the initial formation of the system of indicators, reviewers and reviewers to communicate with the review, the expert advisory committee to open a public debate to resolve major differences and other systems have been established, Review of the results of the examination and approval has been implemented. Bi Jingquan said that in the new year, there are seven main focus of the work. First, to speed up the evaluation of the efficacy of drug quality evaluation work to expand the resources of clinical trials to explore the quality of injections and efficacy of the consistency of the evaluation method to start the traditional Chinese medicine injections drug safety, effectiveness of the re-evaluation work. Second, to encourage innovation in medicine. Improve the drug professional links and data protection system, and to achieve domestic and international clinical data of mutual recognition, reduce the cost of R & D. Third, to establish a review of the leading drug and medical equipment review and approval technical system, to continue to increase drug medical equipment technical review staff and inspectors, and gradually form a technical review as the core, on-site inspection and product testing for technical support Review the approval mechanism. Fourth, the implementation of on-site inspection responsibilities. Strengthen the verification of the authenticity of the declaration data, clarify the legal responsibility of the inspectors and the supervisory responsibility of the inspection units. Fifth, the establishment of drug varieties file. For each listed drugs to establish a drug prescription, raw materials package materials, quality standards, brochures, post-marketing security information, production process changes and other information database. Sixth, to establish a drug electronic general technical documentation system (eCTD system), for the end of this year to achieve the new system through the implementation of electronic reporting and review. Seventh, we must speed up the process to check. Pharmaceutical production enterprises must be in accordance with the state approved the production process, according to various aspects of the proposed changes to improve, as soon as possible to issue. |
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