摘要
创新药物注册审评制度完善是推动创新药物发展的重要保证。本文拟通过比较中美两国在创新药物技术审评过程中的异同,根据我国具体国情与体制,借鉴美国FDA技术审评经验,提出新药技术审评改进的建议,推进我国创新药审评的规范化与法制化。
The improvement of new drug registration approval system is an important assurance for the development of new drug.Differences on new drug technical review between FDA and SFDA are discussed,the experiences of FDA in technical review are connected with the reality of our country to make a suggestion on the improvement of new drug technical review and make the new drug review system more standardized.
出处
《中国药物评价》
2012年第5期317-319,346,共4页
Chinese Journal of Drug Evaluation
关键词
创新药物
注册审评制度
技术审评
New drug
Drug registration approval system
Technical review
