Sichuan will issue opinions to open a green channel for the approval of innovative drugs

Source: Huaxi Metropolis Daily strives to establish a national drug review sub center in Sichuan on January 20, 2016, digest the overstocked stock of variety transfer in Sichuan by the end of 2016, and strive to complete the quality consistency evaluation of national basic drug oral preparation and reference preparation by the end of 2018 A series of measures will be taken around the reform of pharmaceutical and medical devices, which come from the implementation opinions of the people's Government of Sichuan Province on the reform of the review and approval system of pharmaceutical and medical devices On January 20, the client reporter of Huaxi Metropolis Daily learned from the general office of the provincial government that "opinions" will be issued in the near future Focusing on the objectives of improving the evaluation ability, improving the quality of generic drugs, promoting R & D innovation, and improving the evaluation efficiency, Sichuan will implement nine key tasks For example, to open a green channel for innovative drugs to prevent and treat AIDS, malignant tumors, major infectious diseases, rare diseases and other diseases, and speed up their review and approval There are also drugs that need new drugs urgently in clinical practice, which are listed in major national science and technology projects and national key R & D plans, innovative drugs that are transferred to domestic production and children's drugs, as well as innovative drugs that use advanced preparation technology, innovative treatment means and have obvious treatment advantages The opinion also proposes to assist the applicant to carry out clinical trials in China simultaneously for the approved overseas unlisted new drugs Encourage our provincial clinical trial institutions to participate in international multicenter clinical trials We will encourage our province to focus on the development of pharmaceutical and medical devices that are in short supply in the market In particular, Sichuan will reform the approval method of medical devices Encourage the research and development innovation of medical device enterprises in the province, focus on supporting the research and development of medical devices such as biomedical materials, nuclear technology medical equipment, medical imaging equipment, medical testing equipment, tumor treatment equipment, intelligent diagnosis and treatment equipment, traditional Chinese medicine characteristic diagnosis and treatment equipment, high-end consumables, etc., and make the above products, as well as the innovation or first imitation of medicine with core technology patents and significant clinical value The application for registration of medical devices shall be included in the scope of special review and approval, and shall be handled preferentially Adjust the charging standard to further provide guarantee, and the opinion proposes to integrate and merge the charging items of provincial drug and medical device registration, approval and registration In principle, the fee standard for registration of drugs and medical devices shall be assessed every five years, and shall be adjusted appropriately according to the assessment In addition, for the generic drugs passing the consistency evaluation in Sichuan Province, it is allowed to mark on the instructions and labels, and provide support in clinical application, bidding procurement, medical insurance reimbursement and other aspects, and encourage the medical institutions in Sichuan Province to purchase and use according to the principle of "high quality optimization".