广东省医疗机构制剂现状调查与新药转化潜力分析

Survey on Status Quo of the Preparations of Medical Institutions in Guangdong Province and New-Drug-Development Potential Analysis

目的分析广东省医疗机构制剂现状及新药转化潜力,为医疗机构制剂新药转化提供参考。方法在广东省药品监督管理局组织下,采用问卷调研的形式,调研广东省医疗机构制剂数量、销售规模和研发现状。结果广东省内医疗机构制剂众多,新药转化率较低,但其中不乏疗效好、销量好的品种,具有很好的新药转化潜力。结论药品监督管理部门应鼓励医疗机构开展医疗机构制剂的安全性和有效性的临床研究,构建医疗机构和企业交流的平台,促进医疗机构制剂向新药的转化。

OBJECTIVE To analyze the current status of the Preparations of Medical Institutions in Guangdong Province and their capability to develop into new drug,provides information for the New-Drug development.METHODS A questionnaire survey,organized by the Guangdong Provincial Drug Administration,was conducted to investigate the quantity,sales volume and Research and Development(R&D)progress of the Preparations of Medical Institutes in Guangdong Province.RESULTS Number of the Preparations of Medical Institutions is considerable in Guangdong Province,many of them have excellent drug effectiveness and high sales volume,which indicate great potentials to develop into new drugs.However,a few of them was further studied as New Drug candidates.CONCLUSION Drug regulatory department should encourage medical institutions to conduct clinical research on the safety and effectiveness of medical institution′s preparations.A platform should be built up to promote communication between medical institutions and pharmaceutical industry,which can drive the development of the Preparations of Medical Institution into new drug.