Announcement of the General Administration of the people's Republic of China on Soliciting Opinions on relevant policies on encouraging innovation of pharmaceutical and medical devices and speeding up the review and approval of the listing of new pharmaceutical and medical devices (Draft for comments) (No. 52, 2017)

Source: CFDA 2017-05-12 In order to further deepen the reform of the review and approval system, promote the adjustment of the industrial structure and technological innovation of pharmaceutical and medical devices, improve the industrial competitiveness, and meet the clinical needs of the public, the State Food and drug administration, in consultation with the relevant departments of the State Council, drafted the relevant policies on encouraging the innovation of pharmaceutical and medical devices to accelerate the review and approval of the listing of new medical devices (Draft for comments), We are now open to the public for comments It is suggested that the modification opinions be fed back to the State Food and Drug Administration (drug and cosmetic registration administration department) by email before May 25, 2017 The deadline for consultation is June 10 The amendment of laws and regulations in the draft shall be carried out according to relevant procedures Email: yhzcszhc@cfda.gov.cn is hereby announced Annex: relevant policies on encouraging innovation of medical devices to accelerate the review and approval of new medical devices on the market (Draft for comments) relevant policies on encouraging innovation of medical devices to accelerate the review and approval of new medical devices on the market (Draft for comments) attached by food and Drug Administration on May 11, 2017 1、 Accelerate the evaluation and approval of medical devices urgently needed in clinical practice If the early and mid-term indicators of clinical trials show curative effect and can predict the clinical value of the medical devices and other medical devices that have great significance in solving the clinical needs for the treatment of serious life-threatening diseases without effective means of treatment, they can be approved for marketing The applicant shall formulate a risk control plan, conduct confirmatory clinical trials as required and complete the research content specified in the approval document We will encourage the research and development of innovative drugs and medical devices, and give priority to the review and approval of innovative drugs and medical devices listed in major national science and technology projects and supported by national key research and development plans 2、 Support the research and development of rare disease treatment drugs and medical devices The Department of health and family planning shall publish the catalogue of rare diseases and establish a registration system for patients with rare diseases Applicants for rare disease treatment drugs and medical devices can apply for relief of clinical trials and accelerate the review and approval of medical devices for rare disease treatment For rare disease treatment drugs and medical devices that have been approved to be listed abroad, they can be approved to be listed conditionally, and relevant research can be made up within the specified time after listing 3、 Strictly review and approve the injection Strictly control the change from oral preparation to injection If the oral preparation can meet the clinical needs, the injection preparation will not be approved for listing; if the muscle injection preparation is changed to intravenous injection preparation, the intravenous injection preparation will not be approved for listing if the muscle injection preparation can meet the clinical needs The application for changing dosage form between large volume injection, small volume injection and sterile powder injection for injection shall not be approved if there is no obvious clinical advantage 4、 Adjust the management mode of pharmaceutical raw and auxiliary materials and packaging materials Formulate the management measures for the filing of raw and auxiliary materials and packaging materials, establish the filing information platform for raw and auxiliary materials and packaging materials, and relevant enterprises shall submit the filing materials as required and be responsible for the authenticity of the filing information The drug evaluation institution shall review and approve the raw and auxiliary materials and packaging materials recorded on the information platform together with the drug registration application Pharmaceutical production enterprises shall be responsible for the quality of the selected raw and auxiliary materials and packaging materials 5、 Improve the evaluation system of medical devices Form a technical review system with review as the lead and inspection as the support Establish a drug review team mainly composed of clinical medical professionals, pharmacy, pharmacology, toxicology, statistics and other professionals to review new drugs; establish a medical device review team composed of clinical medicine, clinical diagnosis, machinery, electronics, materials, biomedical engineering and other professionals to review innovative medical devices Establish the project manager system, be responsible for the communication and organization of the meeting between the applicant and the reviewer, and prohibit the reviewer from communicating with the applicant privately Establish the meeting communication system between the reviewer and the applicant in the process of project review There are three important nodes before the application of phase I clinical trial, before the start of phase III clinical trial after the end of phase II clinical trial and before the application of production and listing after the end of phase III clinical trial The meeting between the applicant and the reviewer must be held for full discussion and exchange During the review, meetings and exchanges may be arranged at the request of the applicant An expert advisory committee system shall be established Major technical disputes shall be publicly demonstrated by the expert advisory committee, which shall listen to the opinions of both the applicant and the reviewer and put forward suggestions for decision-making reference The review conclusions of the review institutions shall be open to the public (except for the trade secrets involving the production process and parameters of the enterprise), and shall be subject to social supervision We will unify the technical standards for the evaluation of class II medical devices and create conditions for the gradual realization of the national unified evaluation 6、 Support the clinical application of new drugs Medical institutions are encouraged to give priority to the purchase and use of new drugs with clear efficacy and reasonable price We will study and improve the dynamic adjustment mechanism of the medical insurance drug catalog, explore the establishment of a medical insurance drug payment standard negotiation system, and support innovative drugs to be included in the payment scope of basic medical insurance as required All localities may, according to the needs of disease prevention and control, organize centralized procurement with provinces (autonomous regions, municipalities directly under the central government) as the unit 7、 Support the inheritance and innovation of traditional Chinese medicine We will implement the relevant provisions of the Chinese medicine law of the people's Republic of China, properly handle the relationship between maintaining the curative effect advantage of traditional Chinese medicine and the requirements of modern drug development, properly handle the relationship between traditional drug use patterns and modern drug use needs, and establish and improve the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine Innovative traditional Chinese medicine shall be reviewed and approved according to the standard of "new efficacy"; improved new traditional Chinese medicine shall be able to reflect the advantages of clinical application; classic famous Chinese medicine shall be reviewed and approved according to the simplified standard; natural medicine shall be reviewed and approved according to the standard of modern medicine To carry out the evaluation of the market value and resources of traditional Chinese medicine, guide the research and development of new traditional Chinese Medicine Guided by clinical value, and promote the sustainable utilization of traditional Chinese medicine resources Strengthen the quality control of traditional Chinese medicine, improve the clinical research ability of traditional Chinese medicine We will encourage the use of modern science and technology to research and develop traditional Chinese patent medicines, support the development of new Chinese medicine based on traditional Chinese medicine dosage forms, and promote the healthy development of the Chinese medicine industry 8、 Establish a priority review and approval system based on compulsory patent licensing According to the relevant provisions of the patent law of the people's Republic of China, in order to maintain public health and in case of major threat to public safety, the applicant can apply to the intellectual property department for compulsory license If the intellectual property department decides to implement the compulsory license of drug patent, the drug evaluation agency shall give priority to the review and approval of the registration application for compulsory license The situation where public security is seriously threatened and the procedure for initiating compulsory permission shall be specified by the health and family planning department.