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

ABSTRACT

There has been more than 60000 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.