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Drug entrustment of production approval regulations will be enhanced by technology review
Release time: 2013-11-20 & nbsp & nbsp & nbsp Source: Anonymous

    To regulate drug commission production,Make sure the quality of drug production,The State Drug Administration issued the "Regulations on the Management of Pharmaceutical Entrusted Production Approval Stake Sports Betting(Draft My stake betting appfor Consultation)" (hereinafter referred to as "Opinions"),Regulations for the formation of drug entrusted production approval management,Technical requirements for strengthening drug entrusted production approval links,Legal liability for the quality of drugs shall be borne by the commissioner。
 
"Opinions" strengthened the technical requirements of the drug entrusted production approval link。Opinions point out,Provincial Food and Drug Administration, where the commissioner is located, organizes the acceptance of the application materials commissioned by drugs,Based on the current "Measures for the Supervision and Management of Drug Production",It is emphasized that the first application for drug commissioning for production,Check the trustee production site,Focus on the production conditions of the trustee、Technical level and quality management and the prescription of drugs for trustee、Production process、Quality Standard and Consistency of the Council。
 
Facts,The technical censorship of strengthening drug commissioned production has always been called Stake Sports BettingStake Sports Bettingfor the industry。Industry insiders pointed out,The administrative requirements of commissioned production approval links in the existing regulations are more specific,There are few technical requirements,As a result, there are many hidden dangers of the existing drug commissioning production。
 
"Opinions" clarify the legal liability of drug quality shall be borne by the commissioner。The client needs to confirm the conditions and abilities of the trusted production of the trustee,At the same time,During the commissioning production period,Effective supervision of the production management and quality control of the trustees should be approved by quality technicians,To ensure the quality of the support for the production of drugs。This also makes the commissioner's responsibility more clear。
 
It is worth noting is,This year's two sessions called for the implementation of the drug listing license holder (MAH) system,I did not let go of this "Opinions"。MAH system refers,Whether the drug can go on the market is not necessary to contact whether the MAH has a stake online sports bettingstake sports betting appproduction license,Very common abroad。But the domestic emphasis on & ldquo; the commissioner should be a pharmaceutical manufacturer that has obtained the application of the drug approval document & rdquo;,This opinion is still not let go。
 
"Opinions" also pointed out,Anesthesiologist、Psychiatric drugs、Pharmaceutical Easy toxic chemicals, as well as preparations containing pharmaceuticals and prone toxic chemicals、Biological Products、Multiple groups of demented drugs、Traditional Chinese medicine injections and raw materials must not be commissioned to produce; commissioned production of radioactive drugs shall be handled in accordance with relevant laws and regulations。The State Drug Administration can adjust the medicines that are not entrusted to produce according to the needs of the supervision and management。