News
EMA: Updated EMA Post-authorisation procedural advice guidance
30.06.2010
This guidance addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMA position on issues, which
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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
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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
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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
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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
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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
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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. ...