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2002年12月1日我国《药品注册管理办法》试行正式实施,本办法是《新药审批办法》、《新生物制品审批办法》、《新药保护和技术转让的规定》、《仿制药品审批办法》和《进品药品管理办法》五个办法总的一个修改办法。为了使广大新药研制和生产单位更好地理解、执行这一新的办法,国家药品监督管理局(SDA)对本局有关执法人员、各省、市SDA的执法人员、SDA药品审评中心、检定所及国内外新药研究和生产的单位和企业从2002年11月~12月进行了分批、分期的培训,参加培训人员约3000多人。
The Measures for the Examination and Approval of New Drugs, the Measures for the Examination and Approval of New Biological Products, the Provisions on the Protection and Transfer of New Drugs, the Measures for the Examination and Approval of Generic Drugs, the Measures for the Administration of Drug Registration in China were officially implemented on December 1, 2002, And “imported drugs management approach” five ways a total change. In order to make the new pharmaceutical research and manufacturing units better understand and implement this new measure, the State Drug Administration (SDA) conducted a review on the law enforcement officers of this Council, law enforcement officials of SDA in various provinces and municipalities, the SDA Center for Drug Evaluation, At home and abroad, the units and enterprises that engaged in the research and production of new drugs started training in batches and staged from November to December in 2002 with about 3,000 trainees.