欧洲药品管理局EMA (The European Medicines Agency，简称EMA)，输入网址https://www.ema.europa.eu/en，进入EMA官网首页：最上方，导航栏包括：Medicines医药、Human regulatory人用药品监管、Veterinary regulatory兽用药品监管、Committees委员会、News & events新闻和活动、Partners & network合作伙伴和网络和About us关...
“Veterinary regulatory兽用药品”,包括:1)Overview概述,有兽药整个生命周期中,各阶段法规/指南主题链接等。2)Research and development研究和开发,为兽药制剂的开发和设计提供指导,包括:Availability of veterinary vaccines兽医疫苗的供应情况、Compliance法规、Ethical use of animals动物伦理、Innovation in medicines药物创...
EMA - Veterinary Scientific Guidance UpdateNew:Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3. Reference Number: EMA/CVMP/426245/2023. Status: Draft Consultation end 31JAN2025.Summary: This guideline replaces the Reflection paper ...
PRODUCTS 包括八种类型产品:Food(食品)、Drugs(药品)、Medical Devices(医疗器械)、Radiation-Emitting Products(放射性产品)、Vaccines, Blood, and Biologics(疫苗、血液和生物制品)、Animal and Veterinary(动物和兽医制品)、Cosmetics(化妆品)、To...
the European Medicines Agency's (EMA) committee responsible for veterinary medicines.The CVMP was established in line withRegulation (EC) No 726/2004。兽用药品委员会是EMA负责兽药的专门机构。CVMP根据Regulation (EC) No 726/2004而建立。 List of national competent authorities in the EEA (EEA区域兽药...
The Annex “Decision trees for the selection of sterilisation methods” (EMEA/CVMP/065/99) to the note for guidance: Development pharmaceutics for veterinary medicinal products (EMEA/CVMP/315/98). 附录兽药研发指南注释(EMEA/CVMP/315/98)“...
Veterinary Medicines Division: London, UK, 2013.European medicines Agency (EMA).European medicines Agency Guideline on bioanalytical method validation. http://www.tga.gov.au/pdf/euguide/ewp1922172009.pdf 28 June, 2013.Anonymous (2013a). European Medicines Agency (EMA). Revised ESVAC reflection ...
截止2022年6月,美国、欧盟、中国、日本、韩国、加拿大、巴西等均发布了适合本区域或本组织的生物分析指导原则。这些原则主体内容虽然基本相似,但具体细节并非完全相同,个别验证参数上也存在一定差异。 本期,我们将对在世界范围影响力深远且有代表意义的FDA、EMA,以及对我国的生物分析领域具有明确指导意义的2020中国药典90...
Committee for Medicinal Products for Human use (CHMP) Committee for Medicinal Products for Veterinary use (CVMP)Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container 药品、活性物质、辅料和内包材的灭菌指南 This guideline replaces the document Decision...
forveterinarymedicinalproducts(EMEA/CVMP/315/98). 本指南取代了灭菌方法选择的决策树文件(CPMP/QWP/054/98),该文件是药品研发指 南说明(CPMP/QWP/155/96)的附件;以及灭菌方法选择的决策树文件(EMEA/CVMP /065/99),该文件是指南说明的附件:兽药产品开发药剂学(EMEA/CVMP/315/98)。