两法实施后药品监管法律法规体系的构建与展望

Prospect and Construction of Drug Regulatory Laws and Regulations system after the Implementation of the Two Laws

本文回顾新修订《药品管理法》《疫苗管理法》实施后配套法律法规文件的发布,特别是在《专利法》修正引入专利权限期补偿和专利纠纷早期解决条款,《刑法》修正调整假药、劣药等犯罪处罚条款。药品注册、生产管理方面配套文件发生重大变化。此外,国家药监局发布系列文件或复函,明确违法行为定性和案件查办问题。未来,两法配套法规文件发布将稳步推进。

This paper reviewed the publication of supporting laws and regulations documents after the implementation of the latest amended Drug Administration Law and the Vaccine Administration Law,especially the introduction of patent extension and early settlement mechanism for patent dispute in the amendment to the Patent Law,and the adjustment of criminal punishment provisions for fake and inferior drugs in the amendment to the Criminal Law.Major changes have taken place in the supporting documents of drug registration and production management.In addition,National Medical Products Administration has issued a series of documents or replies to clarify the nature of illegal acts and the investigation and handling of cases.In the future,the supporting laws and regulatory documents of the two laws will be steadily issued.