非处方药临床审评相关要求（Non prescription drug clinical reviews related requirements）.docVIP

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非处方药临床审评相关要求（Non prescription drug clinical reviews related requirements）.doc

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非处方药临床审评相关要求（Non prescription drug clinical reviews related requirements）

非处方药临床审评相关要求（Non prescription drug clinical reviews related requirements） [release date][column] evaluation of chemical drugs [title] requirements related to clinical reviews of OTC drugs [text] PFONT size=2EM review two clinical group Zhao Jianzhong /EM /FONTBRBRFONT size=2 Drug Administration Law provisions of article thirty-seventh, the State adopts a classification system for prescription and non prescription drugs for drug. It is an important content of drug supervision and management and also an international model of drug administration that pharmaceutical products are established according to prescription and OTC drugs. Promoting drug classification management in an all-round way plays an extremely important role in ensuring the safety and effectiveness of the use of drugs and promoting the healthy development of medical and health undertakings. Through efforts, China has initially established a prescription drug and non prescription drug classification management system and working system. With the implementation of drug classification system, non prescription drug registration application has gradually increased, this article makes a summary of the relevant requirements of relevant laws and regulations on the clinical research of non prescription drugs, to obtain a more comprehensive and clear concept to. /FONTBRBRFONT size=2, a prescription and non prescription drugs /FONTBRFONT size=2 classification measures for the administration of prescription and non prescription drugs second drugs according to the varieties, specifications, indications, dosage and route of different drugs according to the prescription and non prescription drugs management. Prescription drugs must be licensed, licensed, or licensed by a practitioner or practitioner. OTC drugs do not need to be judged, purchased, and used on the basis of a practitioner or practitioners prescription. /FONTBRFONT size=2 has now selected and published six batches of 4326 OTC varieties. /FONT /P