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EMA: Guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators - draft

13.06.2013
Risk-minimisation measures are public-health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity ...

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products - draft

13.06.2013
This module addresses the legal requirements detailed in title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

06.06.2013
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...

EMA: Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery

06.06.2013
This guideline is a revision of the CHMP Guideline on clinical investigation of medicinal products for Prophylaxis of Intra- and Post-operative Venous Thromboembolic Risk (CPMP/EWP/707/98 Rev.1 ...

EMA: Guideline on clinical investigation of medicinal products in the treatment of depression

06.06.2013
The present document should be considered as general guidance on the development of medicinal products for acute and long-term treatmentof Major Depressive Disorder (MDD). Its main focus is on ...

EMA: Draft guideline on the clinical development of medicinal products intended for the treatment of pain

06.06.2013
This document is intended to give guidance on the investigation of medicinal products to be used in the treatment of nociceptive pain and / or of central and peripheral neuropathic pain. ...

EMA: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

06.06.2013
Since the publication of the EMA Guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (CPMP/EWP/563/98) in 2000, there has been an intense ...

EMA: Guideline on the use of bovine serum in the manufacture of human biological medicinal products

06.06.2013
This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02). ...

EC: Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to

06.06.2013
These guidelines apply to the variations of marketing authorisations for medicinal products for human use and veterinary medicinal produ cts granted in accordance with Regulation 726/2004, ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogen

23.05.2013
The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential ...