生物制品批签发管理办法2017.DOCVIP

【CLI Code】 CLI.4.307641(EN)? Original Link： HYPERLINK /en_law/a96b6a43fead8e47bdfb.html \t _blank /en_law/a96b6a43fead8e47bdfb.html Measures for the Administration of Lot Release of Biological Products (2017) 生物制品批签发管理办法(2017) Document Number：Order No. 39 of the China Food and Drug Administration Area of Law： Health and Sanitation Level of Authority： Departmental Rules Effective Date：02-01-2018 Issuing Authority： All Administrations Status： Effective Order of the China Food and Drug Administration 国家食品药品监督管理总局令 (No. 39) （第39号） The HYPERLINK javascript:ESLC(53922,0) Measures for the Administration of Lot Release of Biological Products, as deliberated and adopted at the executive meeting of the China Food and Drug Administration, are hereby issued and shall come into force on February 1, 2018. 《 HYPERLINK javascript:SLC(53922,0) 生物制品批签发管理办法》已于2017年12月20日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2018年2月1日起施行。 Director: Bi Jingquan 局长：毕井泉 December 29, 2017 2017年12月29日 HYPERLINK javascript:ESLC(53922,0) Measures for the Administration of Lot Release of Biological Products HYPERLINK javascript:SLC(53922,0) 生物制品批签发管理办法 Chapter I General Provisions 第一章　总 则 Article 1 For the purposes of strengthening supervision and administration of biological products, regulating lot release of biological products, and ensuring the safety and effectiveness of biological products, these Measures are developed in accordance with the relevant provisions of the HYPERLINK javascript:ESLC(252632,0) Pharmaceutical Administration Law of the Peoples Republic of China (hereinafter referred to as the HYPERLINK javascript:ESLC(252632,0) Pharmaceutical Administration Law). 　　第一条　为加强生物制品监督管理，规范生物制品批签发行为，保证生物制品安全、有效，根据《 HYPERLINK javascript:SLC(252632,0) 中华人民共和国药品管理法》（以下简称 HYPERLINK javascript:SLC(252632,0) 《药品管理法》）有关规定，制定本办法。 Article 2 For the purpose of these Measures, lot release of biological products means the supervisory and administrative action by which the China Food and Drug Administration (hereinaft