State Food and Drug Administration: speed up the listing of overseas new drugs and drugs for major infectious diseases in urgent need
2022-06-28
According to the official website of the State Food and drug administration, the State Food and Drug Administration recently issued the notice on Further Strengthening the service work of foreign-funded enterprises (hereinafter referred to as the notice). Among them, the notice requires that we should adhere to the clinical value orientation and speed up the listing of overseas new drugs, drugs for rare diseases, drugs for children, and drugs for major infectious diseases that are urgently needed in clinic, on the premise of ensuring safety, effectiveness and quality controllability. The notice mainly puts forward 8 requirements. In terms of strengthening the assistance to enterprises, the notice requires that the reform of "release, management and service" should be deepened, and scientific and effective means and methods should be further adopted in the registration and application of drugs and machinery, the registration and filing of cosmetics and supervision, so as to fully consider the problems and difficulties faced by enterprises and provide good services for enterprises while meeting the regulatory needs. In terms of innovative supervision methods, the notice requires to vigorously promote the construction of drug information traceability system and improve the intelligent supervision ability of "two products and one device". We will fully implement the system of drug marketing license holders, medical device registrants (filers) and cosmetics registrants (filers). Accelerate the construction of Guangdong Hong Kong Macao Bay area, actively implement the work plan for innovative development of drug and medical device supervision in Guangdong Hong Kong Macao Bay area, steadily promote the innovative development of drug and medical device supervision in Guangdong Hong Kong Macao Bay area, and support Hong Kong and Macao drug listing permit holders and medical device registrants to produce their drugs and medical devices in 9 qualified enterprises in the mainland of Guangdong Hong Kong Macao Bay area. In terms of accelerating the review and approval of products urgently needed for innovation, the notice requires that the review and approval of innovative products of medical devices should be accelerated, and the review and approval procedures for innovation and priority should be fully implemented. Support the production of imported medical devices by enterprises in China, and encourage and support the research and utilization of real-world data. Continue to improve the construction of cosmetics regulations and standards system, establish and improve the internal audit mechanism for cosmetics technical review, study and formulate the construction scheme of cosmetics safety evaluation technical support system, formulate technical guidelines for safety evaluation of new raw materials, and preliminarily establish a safety evaluation database. In terms of promoting the implementation of the drug patent linkage system, the notice requires that, according to the measures for the implementation of the early resolution mechanism for drug patent disputes (Trial), we should continue to promote the implementation of relevant systems such as information disclosure, patent registration, generic drug patent declaration, judicial link and administrative link, and the first generic drug market monopoly period, and continue to refine and improve relevant specific work requirements according to practical needs. In terms of actively promoting the transformation of international rules, the notice requires to strengthen international regulatory exchanges and cooperation, deeply participate in the formulation of international regulatory rules, actively transform and implement international technical standards and guidelines, and promote regulatory modernization through regulatory internationalization. Actively participate in the formulation and revision of international rules, deeply participate in the work of the World Health Organization (who), the international alliance of drug regulators (icmra), the international forum of medical device regulators (imdrf), the international cosmetics regulatory Union (ICCR) and other relevant international organizations, and promote the transformation and implementation of relevant guiding principles. In terms of Comprehensively Strengthening the building of drug regulatory capacity, the notice requires that in view of the regulatory needs in the development of new technologies, new products and new business forms in the current pharmaceutical field, we should focus on the frontier, highlight the key points, develop and apply a number of new regulatory tools, new standards and new methods, and improve our ability to solve regulatory problems. In terms of unblocking the communication channels of enterprise appeals, the notice requires that enterprises collect their appeals and sort out the problems encountered by enterprises in registration, filing, production and operation in a timely manner. Carry out the publicity, implementation and interpretation of laws and regulations through various forms such as enterprise seminars and publicity training, and focus on relevant common problems in supervision. In terms of further strengthening drug safety supervision, the notice requires to strengthen the supervision of high-risk key products, comprehensively strengthen the quality supervision of drug and mechanical products for epidemic prevention and control, and adhere to the combination of special sampling inspection and daily supervision and inspection. Strengthen the publicity, implementation and training of cosmetics registrants (recorders) and continue to strengthen supervision. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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