Health & Beauty

Recently, the General Department of the State Food and Drug Administration issued the "Notice on Further Strengthening the Services of Foreign-funded Enterprises", proposing eight measures to speed up the review and approval of products that are urgently needed for innovation.

The first is to intensify efforts to help enterprises. Deepen the reform of "delegating power, delegating power, delegating power and improving services", further adopting scientific and effective means and methods in the application of drug registration, cosmetics registration and supervision, etc., while meeting the needs of supervision, fully consider the problems and difficulties faced by enterprises, and provide good services for enterprises .

The second is to innovate regulatory methods. Vigorously promote the construction of drug information traceability system, and improve the intelligent supervision ability of "two products and one machine". Fully implement the system of drug marketing license holders, medical device registrants (filers), and cosmetic registrants (filers). Accelerate the construction of the Guangdong-Hong Kong-Macao Greater Bay Area, actively implement the "Guangdong-Hong Kong-Macao Greater Bay Area Drug and Medical Device Regulatory Innovation and Development Work Plan", steadily promote the Guangdong-Hong Kong-Macao Greater Bay Area drug and medical device regulatory innovation and development, and support Hong Kong and Macao drug marketing license holders, The medicines and medical devices held by the medical device registrant shall be produced by qualified enterprises in 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area.

The third is to speed up the review and approval of products that are urgently needed for innovation. Adhere to the orientation of clinical value, under the premise of ensuring safety, effectiveness and quality controllability, continuously optimize the review and approval process and improve the efficiency of review and approval. Give full play to the role of the four fast-track drug reviews, and speed up the launch of overseas new drugs, drugs for rare diseases, children's drugs, and drugs for major infectious diseases that are urgently needed in clinical practice. Accelerate the review and approval of innovative medical device products, and fully implement the innovation and priority review and approval procedures. Support the production of imported medical device products 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 cosmetic technical review, study and formulate the construction plan for the technical support system for cosmetic safety evaluation, formulate technical guidelines for the safety evaluation of new raw materials, and initially establish a safety evaluation database.

The fourth is to promote the implementation of the drug patent link system. According to the promulgated "Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial)", the implementation of relevant information disclosure, patent rights registration, generic drug patent declarations, judicial links and administrative links, and the first generic drug market exclusivity period have been continuously promoted and implemented. Continue to refine and improve relevant specific work requirements according to practical needs.

Fifth, actively promote the transformation of international rules. Strengthen international drug 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, and deeply participate in the work of relevant international organizations such as the World Health Organization (WHO), the International Alliance of Drug Regulatory Authorities (ICMRA), the International Forum of Medical Device Regulatory Authorities (IMDRF), and the International Cosmetics Regulatory Alliance (ICCR) to promote Relevant guiding principles are transformed and implemented.

Sixth, comprehensively strengthen the construction of drug regulatory capacity. Conscientiously implement the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building" issued by the General Office of the State Council, and accelerate the implementation of China's scientific action plan for drug regulatory. In response to the current regulatory needs in the development of new technologies, new products, and new formats in the pharmaceutical field, focus on the frontiers, highlight key points, develop and apply a number of new regulatory tools, new standards, and new methods to improve the ability to solve regulatory problems.

The seventh is to unblock the communication channels for corporate demands. Do a good job in the collection of enterprise appeals, and timely sort out the problems encountered by enterprises in registration, filing, production, operation and other links. Carry out publicity, implementation and interpretation of laws and regulations through corporate forums, publicity and training and other forms, and focus on relevant common issues in supervision.

Eighth, to further strengthen drug safety supervision. Strengthen the supervision of high-risk key products, comprehensively strengthen the quality supervision of medical equipment for epidemic prevention and control, and adhere to the combination of special sampling inspections and daily supervision and inspections. Increase the publicity and training of regulations for cosmetic registrants (filers), and continue to strengthen supervision.