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EMA: Draft guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs)

29.06.2010
Duplicate cases can pose significant problems for analysing signals arising from pharmacovigilance databases, both artificially inflating and masking signals of disproportionate reporting. The ...

EMA: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

29.06.2010
This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its ...

Questions & Answers - The use of eCTD on MRP/DCP

08.06.2010
Questions & Answers covering issues of eCTD dossier submission and handling under the new variations regulation. ...

Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

08.06.2010
The allocation of the Variation procedure number is partly in the hands of the MAH. This guide will give detailed guidance on this issue. ...

EMA/CMDh explanatory notes on Variation Application Form

08.06.2010
This document is intended to provide more clarification on how the new Variation Application Form should be completed. It will be regularly updated as more experience is gained once Commission ...

Public consultations have been launched on List of fields for result-related information to be submitted to the EudraCT clinical trials database, and to be made public

08.06.2010
Public consultation document: Draft Implementing technical guidance - List of fields for result-related information to be submitted to the \'EudraCT\' clinical trials database, and to be made ...

Report on rewards and incentives under the Paediatric Regulation

08.06.2010
The Paediatric Regulation (Regulation (EC) No 1901/2006) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals ...

New guidance document added to the regulation of blood section

10.05.2010
A new guidance document has been added to the section on how we regulate blood. ...

Medicinal products for the treatment of alcohol dependence

27.04.2010
Overview of comments received on the draft guideline on the development of medicinal products for the treatment of alcohol dependence. ...