英文译稿《中国药品管理法》2019版.pdfVIP

Drug Administration Law of the People’sRepublic of China (2019 Revision) Promulgation Authorities: Standing Committee of the National Peoples Congress Promulgation Date: 2019.08.26 Effective Date: 2019.12.01 Validity Status: forthcoming Document Number: Presidential Decree No. 31 Drug Administration Law of the Peoples Republic of China (2019 Revision) The revised Drug Administration Law of the Peoples Republic of China passed by the 12th Session of the Standing Committee of the 13th National Peoples Congress on 26 August 2019 is hereby promulgated and shall be implemented with effect from 1 December 2019. 26 August 2019 Passed by the Seventh Session of the Standing Committee of the Sixth National Peoples Congress on 20 September 1984 First amendment by the Twentieth Session of the Standing Committee of the Ninth National Peoples Congress on 28 February 2001 First revision on 28 December 2013 pursuant to the Decision of the Standing Committee of the National Peoples Congress on Revision of Seven Pieces of Legislation Including the Marine Environmental Protection Law of the Peoples Republic of China passed by the Sixth Session of the Standing Committee of the Twelfth National Peoples Congress Second revision on 24 April 2015 pursuant to the Decision on Revision of the Drug Administration Law of the Peoples Republic of China passed by the Fourteenth Session of the Standing Committee of the Twelfth National Peoples Congress Second amendment by the Twelfth Session of the Standing Committee of the Thirteenth National Peoples Congress on 26 August 2019 Content Chapter 1 General Principles 3 Chapter 2 Drug Research and Development and Registration 4 Chapter 3 Drug Marketing Authorization Holder 5 Chapter 4 Drug Manufacturing 7 Chapter 5 Drug Distribution 8 Chapter 6 Pharmacy Administr