对上市中成药再评价制度的回顾与思考

我国批准上市的中成药批准文号达6万多,其中很大一部分文号是在1985年卫生部颁布《新药审批办法》实施之前由各省、自治区、直辖市药政部门批准,存在质量参差不齐、同一品种由多厂家生产的现象,导致了优质优价中成药的价值难以在市场上体现,影响了中成药市场的良性竞争环境。为此,国家食品药品监督管理局采取了清查批准文号、药品再注册、提高质量标准等多项措施加强上市中成药的价值提升,有效促进了中成药的上市后再评价制度体系的建设和完善。但仍存在质量标准提高与临床价值提升脱节、市场上仍充斥着大量低质低价中成药、中成药再评价工作的质量与效率有待提升等方面的问题。鉴于此,提出了批准文号付费持有,药品安全性、有效性、质量和经济性评价的全面评价体系的完善,第三方评价主体的介入,中成药再评价与中药材GAP管理有效衔接等建议,期望有效促进中成药行业水平提升,并通过再评价与再研究工作,培育出更多的中药大品种。

Review and reflection on re-evaluation system of Chinese patent medicine

There has been more than 60 000 approval numbers of Chinese patent medicines (CPM), among which a large portion were approved by provincial agencies before the Ministry of Health promulgated and implemented them in 1985. One drug was produced by many companies and the available drugs'quality varied among different producers. Drugs with low quality and low price have been flooded into the medicinal market, which has resulted the drugs in high quality are closed outside the market. The benign competition in CPM market has been influenced. Many measures to improve the quality of the marketed drugs have been taken by State Food and Drug Administration, including checking the approval numbers, re-registration, and quality improving actions, so as to strengthen the listed medicine value promotion, effectively promote the CPM listed in the market after the re-evaluation system construction and perfect. But there are still the disconnect between improving the quality standard and enhancing the clinical value of the quality and efficiency; The market is still filled with a large number of low quality and low cost of proprietary CPM, the re-evaluation work of CPM and other issues need to be improved. Nonetheless, to put forward the suggestion on that the approval numbers should be held by payment, the comprehensive evaluation system on drug safety, effectiveness, quality, and the economic value should be improved, the evaluation by the third party should be intervened, and the re-evaluation of CPM and GAP adminstration of genuine medicinal materials should be effectively linked up. We expect the improvement of industrial level of CPM and the cultivation with a large variety of CPM through the re-evaluation and re-study.