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The registration approval of health care products will be compressed within 170 working days
Release time: 2016-11-21 & nbsp & nbsp & nbsp Source: Anonymous
  The State Food and Drug Administration issued the "Rules for the Working and Approval Work of Health Food Registration Review and Approval" on November 17th.,It will promote My stake betting appstake online sports bettinghealth food from external review system to the internal review system that is mainly reviewed by staff of the health food review center,Improve review efficiency and consistency。
 
  Display according to the Details,Administrative review should be completed in 20 jobs,Please review the materials for not more than 60 working days,On -site inspection does not exceed 30 working days、Review inspection does not exceed 60 working days,Administrative review should be completed in 20 jobs,Reflecting the simplified administration and decentralization、Regulatory ideas combined with the pipe tube。
 
  Waiting for registered applicants to receive notice of review opinions、Waiting for registered applicants to approve the certification document sample draft、Waiting for the registration applicant to submit supplementary materials、On -site check、Review inspection、Time to review,Standard time for technical review,Not included in the review time limit。
 
  According to 39 Medicine Jun,,The registration and approval of future stake online sports bettingstake betting apphealth products will establish the work mode of the expert review team,Safety consists of review experts、Health care function、Craft、Product technical requirements Expert review team,Responsible for the safety of the product、Health care function、Craft、Quality Standard for review,Form the conclusion of review。
 
  The review center is responsible for reviewing and summarizing the review report of the expert review team,Course with the application materials、On -site inspection and review inspection,issue a comprehensive review conclusion。
 
  Can the product specifically be registered for review? "Details" pointed out,Two -thirds of experts with consistent review opinions and suggestions,The basis for the review report for the review team of the experts。Without two -thirds of experts in unanimous opinions,The reasons that should not be recorded in detail,Suggestions for organizing expert demonstrations,The review center organizes expert demonstrations to demonstrate the dispute issues。
 
  stake betting appDetails optimized the My stake betting appreview and approval process,Insufficient basis、Information is not complete、Insufficient R & D, etc., cannot fully prove product safety、Many situations of health care function and quality controllability,All include & ldquo; I suggest not register & rdquo; conclusion judgment basis,Implementing product health functions、One -time review of safety and quality controllability。
 
  Some relevant person pointed out,Regulatory work of future health products registration approval,The General Administration is not from the head tube to the foot,Strengthen post -post supervision,Constitution -oriented,Solve the problem that the previous industry reflected the long limit of review。