国家创新药物研究与开发体系建设及发展战略

National new drug research and development systemconstruction and developing strategy

国家科技攻关重中之重项目“新药研究与产业化开发”在“九五”期间的成功实施 ,使我国新药研究与开发的能力有了很大提高 ,已基本形成覆盖全国的新药筛选、安全评价和临床试验研究体系 ,能够严格按国际规范要求开展新药研究工作 ,在全国起到了很好的引导和示范作用 ;新药研究的创新意识普遍增强 ,推出了一批高质量的新药研究成果 ,为进一步开展新药研究储备了一批项目 ;培养了一大批技术骨干和学科带头人 ;提高了新药研究与开发的综合实力与整体水平 ,为新药研究与医药产业的发展奠定了坚实的基础 ,取得了巨大的经济效益和社会效益。“十五”期间 ,“创新药物研究与产业化开发”项目将作为国家“八六三”计划重大专项 ,重点放在以下 5个方面 :①建立完善的现代化新药筛选体系。②针对重大疾病开发一批具有自主知识产权的创新药物。③大力开展药物制剂技术与药物新剂型的研究。④加强创新药物研究与开发平台技术和关键技术研究。⑤针对前景可观的创新药物重点品种 ,建立相应的产业孵化基地。

National New Drug Research and Development Project', the key project of nation's 9th five-year-plan, has achieved great success after 5 years' implementing. First, the project promote the formation of national new drug screening, pharmacology and toxicology studies and clinical studies system, which was carried out by the establishment of international standard drug screening, GLP and GCP study centers. Secondly, the project has provided many prosperous new drug candidates, which would serve China's pharmaceutical industry very well. In the meantime the project has built up a strong working force for R&D of new drugs with experienced young scientists. In conclusion 'National New Drug R&D Project' in 9th five-year-plan took the systematic strength of national new drug R&D to a higher level. In 10th five-year-plan the Ministry of Science and Technology will keep on supporting new drug research and development and list 'National New Drug Research and Development Project' as one of key project of '863 Program'. The project will make great efforts to: 1.establish an advanced modern national new-drug-screening system; 2.discover and develop several novel drugs which owns intelligence property right; 3.strengthen pharmacy and new pharmaceutical form studies; 4.support key technology studies related to new drug research and development; 5.establish industrialization bases for prosperous new drugs.