Aktualności
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. ...
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. ...
Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product
27.04.2010
This guideline is intended to provide advice on the preparation of annual reports on the state of development of an orphan medicinal products. ...
Annual Report of the Pharmacovigilance Inspectors Working Group for 2009
27.04.2010
This document is the second Annual Report of the PhV IWG. The PhV IWG focuses on harmonization and co-ordination of PhV related activities at Community level. ...
Public consultation on Annex 2 of the GMP laying down the guidelines for the manufacture of biological medicinal substances and products for human use
27.04.2010
Annex 2 is proposed to be revised as a consequence of the restructuring of the GMP guide, the increased breadth of biological products to include several new product types such as transgenic
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