Authority News

2011 9 November 2011: New Concept Paper on Annex 16 of the EU-GMP Guide 22 August 2011: EU GMP Guide: new Requirements added for Batch Certification 17 May 2011: New Annex 14: Consequences for QPs 6 May 2011: DMA defines new requirements for Qualified Persons in pharmaceutical companies 17 January 2011: EMA publishes two Documents on the QP Declaration concerning GMP Compliance of the API 2010 19 November 2010: Will there soon be a shortage of QPs? 15 September 2010: Free Access to WHO Inspection Reports 15 June 2010: New Practice for Authorisation of Qualified Persons on Section 39 Authorisations 2009 25 February 2009: EMEA Publishes New Version of the Reflection Paper on QP Discretion 2008 23 April 2008: Draft Annex 13 Released: Section 44 Reworded to Enhance Understanding of the Two-Step Release Procedure 11 April 2008 European Commission: Public consultation on revisions of GMP Annex 11 on Computerized Systems and related changes in GMP Part I/ Chapter 4 on Documentation 10 April 2008 European Commission: Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC 19 March 2008 EMEA: Canada and EU agreed to cover Canadian natural health products under the scope of the MRA 17 March 2008 EMEA: Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines 13 March 2008 EMEA: Reflection Paper on Water for Injection Prepared by Reverse Osmosis 11 March 2008 European Commission: Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines 4 March 2008 European Commission: Adoption of the Commission proposal on variations (co-decision part) 18 February 2008 EMEA: GMP Annex 1 of the GMP Guide has been revised 18 February 2008 EMEA: Revision of GMP Guidelines to implement concept of Quality Risk Management 12 February 2008 EMEA: An update on the status of revsion of Chapter 5 of the GMP Guide concerning "Dedicated Facilities" 2007 18 December 2007 EMEA: Workplan 2008 for GMP/GDP Inspectors Working Group 17 October 2007 EMEA: Guideline on Stability testing: Stability testing of existing active substances and related finished products 18 September 2007 EMEA: Annex 2 of the GMP Guide 7 August 2007 EMEA: GMP Annex 6 "Manufacture of Medicinal Gases": Draft revision for public consultation 24 July 2007 EMEA: Questions/Answers on implementation of the harmonised microbiological chapters 2.6.12, 2.6.13 and 5.1.4 of the European Pharmacopoeia 28 March 2007: UK MHRA Publishes Guidance for Qualified Persons 2006 21 July 2006 EMEA: Question and Answer Document on GMP matters 24 March 2006 EMEA: GMP Information for QP Compliance with the requirements of the Marketing Authorisation 24 March 2006 EMEA: PAT Presentation of information in Marketing Authorisation dossiers 2005 23 November 2005 EMEA: Questions and Answers on PAT (update concerning process validation)