health care product registration approval will be compressed to 170 working days to complete-最新凯时注册

the state food and drug administration issued on november 17 the "regulations for health food registration review and approval" clearly pointed out that it will promote the transition of health food from an external review system to an internal review system that is mainly reviewed by the staff of the health food review center. review efficiency and consistency.

according to the "detailed rules", the administrative review should be completed within 20 working days, the application materials review should not exceed 60 working days, the on-site verification should not exceed 30 working days, the recheck and inspection should not exceed 60 working days, and the administrative review should be completed within 20 working days. the work was completed within the work, which embodies the regulatory thinking of streamlining administration and delegating powers and combining delegating management.

the time waiting for the registration applicant to receive the review opinion notice, waiting for the registration applicant to check and approve the sample of the document, waiting for the registration applicant to submit supplementary materials, on-site inspection, review inspection, and review time is the technical review stagnation time and is not counted in time limit for review.

it is understood that the future registration and approval of health care products will establish an expert review team working mode. the review experts will form an expert review team for safety, health care functions, technology, and product technical requirements, who are respectively responsible for product safety, health care functions, technology, and technical requirements. the quality standards are reviewed and the review conclusions are formed.

the review center is responsible for reviewing and summarizing the review reports of the expert review team, and combining the review of application materials, on-site verification, and review inspection, to issue a comprehensive review conclusion.

regarding the specific issue of whether a product can pass the registration review, the "detailed rules" pointed out that more than two-thirds of the review opinions and recommendations of the same expert opinion are used as the basis for forming the review report of each expert review team. if there is no consensus of more than two-thirds of the experts, the reasons for the inability to make the review recommendations shall be recorded in detail, and the recommendation of organizing an expert discussion meeting shall be put forward. the review center shall organize an expert discussion to demonstrate the disputed issues.

the "detailed rules" optimizes the review and approval process, and lists many situations that cannot fully prove product safety, health care functions, and quality controllability, such as insufficient basis, incomplete data, insufficient research and development, etc., are listed in the "recommendation not approved" the basis for the judgment of the "registration" conclusion is to realize a one-time review of the product health function, safety and quality controllability.

a related person pointed out that in the future supervision of registration and approval of health products, the state administration will no longer manage from the beginning to the end, strengthen post-mortem supervision, and be results-oriented to solve the problem of the long review period reported by the industry.