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《药品管理法》和《新药审批办法》颁布实施后,新药审批归由卫生部统一管理,但药典品种、部颁品种、保健药品及各省、自治区、直辖市地方标准品种移植和生产的审批,仍由各地进行.根据中央关于“治理、整顿”的精神,结合各地中成药生产审批情况,为做好今后中成药审批工作,我们将各地上报的1988年批准中成药生产的批复文件,进行了汇总、统计,现将有关情况通报如下:
After the promulgation and implementation of the Drug Administration Law and the Measures for the Examination and Approval of New Drugs, the examination and approval of new drugs shall be subject to the unified management by the Ministry of Health. However, the approval and approval of the pharmacopoeia, ministerial varieties, health-care medicines and the transplanting and production of local standard varieties in all provinces, autonomous regions and municipalities In accordance with the spirit of “governance and rectification” of the Central Government and the examination and approval of proprietary Chinese medicines in various places, in order to do a good job in the examination and approval of proprietary Chinese medicines in future, we have summarized the approval documents for the approval of proprietary Chinese medicines in 1988 submitted to various places Statistics, the relevant information is as follows: