Authority News
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"
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
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
23 November 2005 EMEA: Questions and Answers on PAT (update concerning process validation)
