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On May 8 2025 the European Medicines Agency EMA released a concept paper proposing revisions to Part IV of the EU Guidelines on Good Manufacturing Practice GMP specific

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On 8 May 2025 the EMA issued a Concept Paper proposing a revision Eudralex volume 4 Part IV GMP specific to Advanced Therapy Medicinal Products ATMPs Comments to be

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This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice GMP for medicinal products as laid down in Directive 2003 94 EC for

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Commission Directive 91 412 EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products

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The European Medicines Agency EMA has unveiled a concept paper aimed at revising the Good Manufacturing Practice GMP guidelines specific to Advanced Therapy Medicinal

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Regulation EC No 1394 2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 83 EC and Regulation EC No

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Article 5 of Regulation EC No 1394 20072 mandates the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products ATMPs

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Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use all

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This concept paper aims to outline the rationale objectives and proposed changes for updating Part IV GMP specific to ATMP of the good manufacturing practice GMP guide Eudralex