News
Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines
07.12.2016
Guidance reflects European Commission’s notice on the application of the Orphan Regulation
The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of
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EMA: Opening up clinical data on new medicines
25.10.2016
EMA provides public access to clinical reports
As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European
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EC: Pharmacovigilance - Major developments
14.03.2016
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for
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URPL: Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents
30.04.2015
Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents. ...
EMA: Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
16.04.2015
Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The
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EMA: Compilation of individual product-specific guidance on demonstration of bioequivalence
16.04.2015
The general European Union requirements for bioequivalence demonstration are laid out in the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). In addition, the CHMP
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MHRA: Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests
16.04.2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer
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GMP: New EU GMP Annex 15 Revision published - Valid as of 1 October 2015
16.04.2015
In February 2014 the draft for the revision of EU GMP Annex 15 was published (see the GMP-News from 11 February 2014 \"Revision of the EU GMP Annex 15 for Qualification and Validation
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GMP: EU GMP Annex 1: EMA plans the Revision of the Sterile Guide
26.02.2015
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes
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EMA: Draft proposal for an addendum, on transparency, to the \'functional specifications for the European Union (EU) portal and EU database to be audited\'
12.02.2015
This consultation document sets out proposals and options on the application of exceptions in relation to the transparency provisions of the European Clinical Trial Regulation. Once finalised,
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