Shandong deepening drug review and approval system reform and Supporting the inh

Copyfrom： Release time：2018-08-20 The editor：

Shandong deepening drug review and approval system reform and Supporting the inheritance and development of Chinese medicine
       The Press Office of the Shandong Provincial Government held a press conference today. The Shandong Food and Drug Administration, the Provincial Science and Technology Department, the Provincial Health Planning Commission, and the Provincial People's Office of the People's Republic of China interpreted the implementation opinions on deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical medical devices. . With clear opinions, Shandong will deepen its review by reforming clinical trial management, accelerating the evaluation of generic drug conformity, implementing the system of listing license holders, improving the effectiveness of review and approval, supporting the inheritance and development of Chinese medicine, and promoting the application of big data. Reform of the examination and approval system.

Reform clinical trial management
        Support institutions such as medical institutions, medical research institutions, and medical colleges and universities to conduct clinical trials after registration on the national designated website. Encourage social forces to invest in setting up clinical trial institutions. The clinical trial conditions and ability evaluations are included in the medical institution level review, and a separate evaluation and evaluation system is established for the medical institutions that conduct clinical trials. Medical institutions are encouraged to set up full-time clinical trial departments with professional clinical trial researchers. Encourage clinicians to participate in drug and medical device technology innovation activities, and treat clinical trial researchers as equals to clinicians in terms of job promotion and promotion of titles. Improve the ethical review mechanism, establish a provincial clinical trial ethics committee, guide the ethical review of clinical trial institutions, and accept ethical review of clinical trial programs by institutions or registered applicants who do not have ethical review conditions. Provincial clinical trial institutions are encouraged to participate in international multi-center clinical trials. Accelerate the construction of provincial clinical medical research centers and encourage the development of pharmaceutical medical devices and clinical applications.
Accelerate the evaluation of generic drug consistency
        R & D institutions and scientific research personnel are allowed to apply for drug marketing approval, and manufacturers are encouraged to apply for drug listing permission holders through drug registration, generic drug consistency evaluation, and overall corporate relocation, and support multi-point entrusted production. Explore the implementation of the system of medical device listing license holders. Implement the insurance system for listed license holders.

Improve the effectiveness of review and approval

     Implement the “innovation channel”, “quick channel” and “regular channel” administrative approval mechanism, optimize the review and approval process, and implement priority review and approval for innovative products and major projects. The implementation of series and parallel reconciliation approval, through the acceptance of acceptance, merger inspection, and related approval, to improve the coordination of approval. In-depth promotion of the entire process of examination and approval matters online, promote inter-departmental data sharing, the implementation of "electronic licenses", strengthen the evaluation and approval of inspection, inspection, inspection, law enforcement and other aspects of data sharing and analysis. Establish and improve communication and communication mechanisms, improve various service models, build advisory service platforms, and strengthen policy consultation and guidance. Implement early intervention, innovative guidance and guidance for innovative pharmaceutical medical devices, and promote the listing process. Establish a file of medical equipment for listed drugs.

Support Chinese medicine heritage and development

      Strengthen the cultivation of seed medicinal materials and planting bases, and support the construction and development of honey medicinal materials such as honeysuckle, ginkgo, salvia, platycodon, peony, rose, American ginseng and medlar. We will implement the requirements for the quality management of Chinese herbal medicine production and improve the scale and standardized production level of local medicinal materials. Guide Chinese medicine production enterprises to make full use of local medicinal materials and build large-scale Chinese herbal medicine production and processing bases. Establish and improve the traceability system for the origin of Chinese herbal medicines. We will improve the processing standards for traditional Chinese medicine decoction pieces in Shandong Province and promote the innovative development of characteristic Chinese medicine decoction pieces. Adhere to the original thinking of traditional Chinese medicine, support the traditional Chinese medicine compound preparations, and the long-term clinical efficacy verification of medical institutions such as Chinese medicine preparations and other drug approval documents. The filing system is applied to traditional Chinese medicine preparations that are only prepared by using traditional techniques. Medical institutions are encouraged to entrust pharmaceutical manufacturers to produce Chinese medicine preparations. Encourage Chinese medicine institutions to develop a number of medicines and medical devices using modern technologies such as biology, biomimetic and intelligence. Support the use of cloud computing, mobile Internet, Internet of Things and other information technology to develop intelligent TCM health service products, to provide the public with high-level, personalized and convenient TCM health care services.

Advance big data applications
 
     It is connected with the National Center for Health and Medical Data Big Data to strengthen the convergence, analysis and opening of data resources such as health care, medical device supply and production capacity, wearable devices and smart health electronics, and release data dividends. Accurately meet the needs of the society, dynamically adjust the focus of industrial support, and guide the collection of high-quality social resources to innovative, high-end pharmaceutical medical devices.