Latest News

  • 05.08.2010 The European Medicines Agency has published a Concept paper on the revision of the note for guidance on quality of modified release oral and transdermal dosage forms. The document proposes the revision of the note for guidance on modified release products which addresses specific quality requirements for modified release products, particularly the in vitro testing. The revision of the guideline focus on specific aspects in the context of modified release oral dosage forms and in the context of transdermal dosage forms. More information is available on the EMA's website.


  • 05.08.2010 The European Medicines Agency has published a Draft guideline on setting specifications for related impurities in antibiotics. This document provides guidance for marketing authorisation applicants on setting specifications for related impurities in antibiotics (i.e. antibacterial substances) that are fermentation products or semi-synthetic substances derived from fermentation products. More information is available on the EMA's website.


  • 14.07.2010 The revised Part II of the EU GMP Guide, laying down the basic requirements for active substances used as starting materials, will enter into force by 31 July 2010. More information is available on the Commission's website.


  • 07.06.2010 The European Commission has adopted a Regulation amending the REACH Annexes relevant for SDS – Annex II and, to a lesser extent, Annex VI. The revision brings the SDS requirements into line with the Regulation on Classification, Labelling and Packaging (Regulation (EC) No 1272/2008) and with the guidance on the preparation of SDSs as laid down in the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations. More information is available on the Commission's website.


  • 29.03.2010 The European Medicines Agency has adopted a new Guideline on Repeated Dose Toxicity.


  • 28.03.2010 The European Medicines Agency has published a Concept Paper on the Revision of the Guideline on Process Validation, a draft Guideline on Real Time Release Testing, a Concept Paper on the Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation and a draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials for consultation.


  • 28.03.2010 DG Health and Consumers has launched a public consultation on the veterinary Notice to Applicants Volume 6B – Presentation and content of the dossier. The document, in particular the formats, have been updated in accordance with the new Annex I as published in Directive 2009/9/EC. Additionally, certain terms as well as legal references have been adapted. The application form from the beginning of the document has been removed being a stand-alone form since many years. More information is available on the Commission's website.


  • 08.02.2010 The Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2009/C 323/04).” following Article 4(1)(b) of this Regulation was adopted by the Commission on 21 December 2009 and has been published in the Official Journal in all EU languages on 31 December 2009. The guideline applies from 1 January 2010. The Guideline is available on the Commission's website.


  • 08.02.2010 The Commission “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2010/C 17/01)” following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted by the Commission on 21 December 2009 and has been published in the Official Journal in all EU languages on 22 January 2010. The Guideline is available on the Commission's website.


  • 08.02.2010 DG Enterprise and Industry has released an updated version of Chapter 7 “General Information” of the veterinary Notice to Applicants Volume 6A. The revised version provides updates required by Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, The Netherlands, Portugal, Slovakia, Sweden and the United Kingdom and is available on the Commission's website.


  • 20.01.2010 The Committee for Medicinal Products for Human Use (CHMP) has adopted the new "Guideline on the Investigation of Bioequivalence" (CPMP/QWP/EWP/1401/98 Rev. 1). The guideline comes into effect on the 1st August 2010, and will replace the "Note for guidance on the investigation of bioavailability and bioequivalence" (CPMP/QWP/EWP/1401/98) and the related questions in the Q&A document (CHMP/EWP/40326/06). The Guideline is available on the website of the European Medicines Agency.>