Ensure the new rule happen again in traditional Chinese medicine injectable preparation quality safety

Ensure the new rule happen again in traditional Chinese medicine injectable preparation quality safety
It is reported ' Reporter Wang LeMin) Since improving the listing traditional Chinese medicine injectable preparation breed medicines standard constantly from last year, national food medicines supervise the administration bureau issuing 7 technological guidelines yesterday, make the detailed regulation to the quality security of traditional Chinese medicine injectable preparation. 7 technological guidelines involve the production technology, quality control, clinical research, clinical research, risk control, risk benefit appraising, risk governing plan amount to 7 respects. Study the background particularity, craft variety and reality of the composition complexity included to already listing traditional Chinese medicine injectable preparation, the guideline stipulates, traditional Chinese medicine injectable preparation should accuse of the requirement to produce according to technological parameter, craft detail and relevant quality that the technological procedure stipulate strictly, guarantee one of stability of product quality of different batches. The guideline proposes, the compositions included should be basically clear in injectable preparation. The injectable preparation that the effective composition made into, the content of its single composition should be no less than 90%; Multicomponent injectable preparation made, except that the big class content needs to determine the content, the single composition even needs to determine the content. For instance, include yellow ketone, soap glucoside, alkaloid,etc. in some injectable preparation, need to determine the content of total yellow ketone, total soap glucoside, total alkaloid respectively, still need to include and examine the content to the unitarity in yellow ketone, soap glucoside, alkaloid on behalf of the composition separately. The guideline confirms, support without the abundant, normal clinical security data, the intersection of traditional Chinese medicine and injectable preparation that list already should carry on systematic non- clinical the intersection of security and appraisal study, including testing, acute toxicity testing, long-term toxicity testing, preparation security test, hereditary toxicity to test etc. in general pharmacology. To the overly simple current situation of medicines manual of traditional Chinese medicine injectable preparation, the guideline is clear, the intersection of traditional Chinese medicine and the intersection of injectable preparation and producer and security list, study information, improve the intersection of manual and content of bad reaction should list according to medicine, including opportunity, condition and concrete manifestation that the bad reaction takes place, including severity, response type, incidence, last frequency ( Very common, common, accidental, rare) , relation with medicine ( Certainly, probably, possibility,etc.) , clinical symptom, rotating to return etc.. Especially pay attention to damaging the explanation of the situation to allergic response and internal organs. The guideline requires, the injectable preparation manufacturing enterprise of traditional Chinese medicine should make the monitored plan of the risk, launch medicines bad reaction / incident collection, report, analysis, appraise, investigation, emergency processing and starting such jobs as the research, risk minimize and take action after listing.

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