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记者从日前召开的国家药品监督管理局首次行政规章发布会上获悉,新修订的《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》、《进口药品管理办法》等药品管理规章,自5月1日起在全国施行。 此次修订发布的五个行政规章中,强化了药品审批注册技术要求。新修订的《新药审批办法》的主要内容由原来的6章、22条扩展到8章、57条,附件为8个,将13年来关于新药审批管理的一系列规定融合起来,删去一
The reporter learned from the first administrative regulation conference held by the State Drug Administration recently that the newly revised 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 Technology Transfer of New Drugs, the Measures for Examination and Approval of Generic Drugs “,” Regulations on the administration of imported drugs “and other drug regulations, since May 1 in the country. The revision of the five administrative rules issued, and strengthen the technical requirements for drug approval registration. The main content of the newly revised ”Measures for the Examination and Approval of New Drugs“ has been expanded from 6 chapters and 22 articles to 8 articles and 57 articles and 8 appendices. The newly formulated ”Drug Examination and Approval Measures" has incorporated a series of provisions on the examination and approval of new drug administration over the past 13 years,