在欧洲药典子模块项下,有以下几个模块,如:Ph.Eur.online access欧洲药典在线、Pharmeuropa online欧洲药典论坛、Knowledge database知识数据库、How to order如何订购欧洲药典及Publication Ph.Eur欧洲药典出版计划等。 其中,欧洲药典论坛可免费注册,用于查询“虽征求意见但未订入欧洲药典或既往的药典标准”等;而在Knowled...
临床试验透明度提高方面,国际上正在努力提高临床试验完成后报告和数据的透明度,并减少发表偏倚。Reg.(EU)No 536/2014规定试验完成1年内,申办者须将临床试验结果按照标准格式和语言提交至公众可及的欧盟数据库(EU database)。上市许可申请人(MAA)在上市许可申请获得批...
在欧洲药典子模块项下,有以下几个模块,如:Ph.Eur.online access欧洲药典在线、Pharmeuropa online欧洲药典论坛、Knowledge database知识数据库、How to order如何订购欧洲药典及Publication Ph.Eur欧洲药典出版计划等。 其中,欧洲药典论坛可免费注册,用于查询“虽征求意见但未订入欧洲药典或既往的药典标准”等;而在Knowled...
The document describes the requirements on sterilisation of medicinal products, APIs, excipients and primary containers, as well as on the choice of the method of sterilisation. Besides, the document contains two decision trees for the selection of the sterilisation method for products in diverse gale...
45 No. 8 August 2022 【 审评规范 】 欧洲药品管理局(EMA)丹参根或根茎评估报告草案简介 萧惠来 国家药品监督管理局 药品审评中心,北京 100022 摘要 : 欧洲药品管理局 (EMA) 于 2022 年 4 月正式发布了欧洲药品管理局草药药品委员会 (Committee on Herbal Medicinal Products,HMPC)对草药物质丹参 Salvia ...
The number of GMP inspections requests increased by 18.5% in 2016, linked to the growing number of centrally authorised products. 2016年的GMP检查申报增加了18.5%,这与集中审评产品数据增加有关。 2012 2013 2014 2015 2016 368 397 420 567 672 EudraGMDP is a database operated by EMA which support...
Good Clinical Practice Inspectors Working Group 2010 Adopted by the GCP IWG on 20 June 2012 The publication of this report has been delayed due to the migration of inspection data to our new database and the creation of our reporting tool to retrieve the statistics included in this report.
Advanced Therapeutic Medicinal ProductHospital exemptionmarketing authorisationphase III clinical trialBackground: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises cell therapies, gene therapeutics and tissue engineered products. After implementation of the Regulation 1394/2007, only a ...
GMP Guide: Annex 21 (Importation ofmedicinal products)GMP指南:附录21(药品进口) GMP and Marketing Authorisation HoldersGMP和上市许可持有人 Action: Specialised input(职责:提出专家意见) Guideline on the sterilisation of themedicinal product, active substance...
1.INTRODUCTION 介绍 Ageneralconceptofqualificationofimpuritiesisdescribedintheguidelines foractivesubstances(Q3A,ImpuritiesinNewActiveSubstances)ormedicinal products(Q3B,ImpuritiesinNew MedicinalProducts),wherebyqualificationis definedastheprocessofacquiringandevaluatingdatathatestablishesthe biologicalsafetyofanindividual...