State Drug Administration: Further strengthen the service work of foreign -funded enterprises

Zhongxin Jingwei, June 27. According to the website of the State Drug Administration, recently, the Comprehensive Department of the State Drug Administration issued the "Notice on Further Strengthening the Service Work of Foreign Enterprises", and proposed eight measures such as accelerating the approval of innovation and urgent products. Essence

The first is to increase the efforts of corporate assistance. Deepen the reform of the "decentralization service", and further adopt scientific and effective methods and methods in the registered application declaration, cosmetics registration, and supervision. While meeting the needs of the supervision Essence

The second is the method of innovation supervision. Vigorously promote the construction of the pharmaceutical information traceability system, and improve the "two products and one equipment" smart supervision capabilities. Comprehensively implement the system of drug listing permit holders, medical device registrars (recorder), and cosmetics registrar (recorder) system. Accelerate the construction of the Guangdong -Hong Kong -Macao Greater Bay Area, actively implement the "Working Plan for the Innovation and Development of Medical Device Supervision and Innovation of the Guangdong -Hong Kong -Macao Greater Bay Area", steadily promote the development of drug medical device supervision and innovation in the Guangdong -Hong Kong -Macao Greater Bay Area, and support the holders of Hong Kong and Macao drug listing licenses. The medical device registrar will produce the drug medical equipment held in the 9 cities in the Mainland of the Guangdong -Hong Kong -Macao Greater Bay Area.

The third is to accelerate the review and approval of innovation urgent products. Adhere to clinical value -oriented, under the premise of ensuring safety, effectiveness, and quality controllability, continuously optimize the review and approval process of review and improve the efficiency of review and approval. Give full play to the role of four fast channels for drug reviews, and accelerate the market speed of overseas new drugs, rare medical drugs, children's medication, and major infectious diseases. Accelerate the review and approval of medical device innovation products, and fully implement innovation and priority review approval procedures. Support the production and utilization of imported medical device products in China, encourage and support real -world data. Continue to improve the construction of cosmetics regulations and regulations, establish and improve the internal review mechanism for cosmetics technology review, study and formulate the construction plan of the cosmetics safety evaluation technology support system, formulate a technical guide for new raw materials safety evaluation, and initially establish a safety evaluation database.

The fourth is to promote the implementation of the drug patent link system. According to the "Implementation Measures for the Early Solving Mechanism (Trial)" issued by the introduced patent disputes, it has continuously promoted the implementation of relevant information disclosure, patent registration, generic drug patent statement, judicial link and administrative link, and the exclusive period of the first imitation market. Continue refinement and improvement of specific work requirements according to the needs of practice.

Fifth, actively promote the transformation of international rules. Strengthen the international supervision and exchanges and cooperation of drugs, in -depth participation in the formulation of international supervision rules, actively transform and implement international technical standards and guidelines, to supervise the modernization of supervision in internationalization. Actively participate in the revision of the international rules system, in -depth participation in the World Health Organization (WHO), the International Drug Administration Alliance (ICMRA), the International Medical Device Supervision Institution Forum (IMDRF), and the International Cosmetics Regulatory Alliance (ICCR) and other related international organization work to promote Relevant guidance principles transformation and implementation.

Sixth, comprehensively strengthen the construction of drug supervision capabilities. We will conscientiously implement the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capability" and accelerate the implementation of the Chinese Drug Supervision Science Action Plan. In response to the current regulatory needs of new technologies, new products, and new formats in the medical field, focus on cutting -edge and highlighting the focus, develop and apply a number of new supervision tools, new standards, and methods to improve the ability to crack supervision problems.

Seventh, the channels for communication between enterprises are unblocked. Do a good job of collecting corporate demands, and timely sort out the problems encountered by enterprises in the links of registration, filing, production, and operation. Carry out the publicity and interpretation of laws and regulations through various forms such as corporate symposiums, propaganda training, etc., and focus on relevant common issues in supervision.

Eighth is to further strengthen drug safety supervision. Strengthen the supervision of high -risk key products, comprehensively strengthen the quality supervision of the product of the prevention and control of drugs, and adhere to the combination of special random inspection and daily supervision and inspection. Increase the regulations and training of cosmetics registered (filing), and continue to strengthen supervision. (Zhongxin Jingwei APP)

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