中药新药传承发展与创新之路

随着《中华人民共和国药品管理法》《药品注册管理办法》等法律法规的不断完善,药品注册、药品管理等相关文件不断更新,药品监管理念不断发展变革,中药新药的研发愈发成熟。政府的监管促进了药品质量的提高,满足了公众用药需求,为维护人民身体健康提供了强有力的政策保障。对建国以来中药新药研究政策法规及技术要求的发展变化做全面的阐述,从政策法规和审评要求等多方面对中药新药的研发及监管现状进行归纳总结,以期能够对广大新药研发单位及相关生产企业予以启发,更好地推动中医药事业的传承和创新发展。

Inheritance,Development and Innovation of the New Chinese Medicine

With the constant improvement of laws and regulations including The Drug Administration Law of the PRC,Drug Registration Regulation Measures,as well as the continuous update of relevant documents such as drug registration and administration,the concept of drug regulation is constantly evolving and changing.As a result,the research and development of new traditional Chinese medicine has become more mature.The supervision of government had promoted the improvement of drug quality,satisfied the public demand for medication,which provided a strong policy guarantee for the maintenance of people′s health.This paper comprehensively expounded the development and changes of policies,regulations and technical requirements for new Chinese medicine research since the founding of the People′s Republic of China.In addition,the author summarized the development and supervision of new Chinese medicine from the perspectives of policies,regulations and review requirements.In the hope of giving inspiration to the majority of new drug research and development units and related production enterprises,better promoting the inheritance and innovative development of traditional Chinese medicine.