News
EMEA: ICH Q 4 B Annex 10 Step 3 Polyacrylamide Gel Electrophoresis
29.06.2009
This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...
European Commission: Notice to Applicants, Volume 6C Guidance on the Assessment of environmental risks of veterinary medicinal products
29.06.2009
Notice to Applicants, Volume 6C, new guidance document as regards the assessment of environmental risks of veterinary medicinal products resulting from amending Directive 2004/28/EC to Directive
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EMEA: Draft guideline on the clinical evaluation of anti-fungal agents for the treatment and prophylaxis invasive fungal disease
26.06.2009
The guideline is primarily concerned with the content of clinical development programmes to assess the safety and efficacy of antifungal agents administered by oral or parenteral routes for the
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EMEA: Reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products
26.06.2009
This document defines the scope, content and format of the documents to be published by EMEA in connection with the withdrawal of an application for a centralised veterinary product by
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EMEA: Concept paper on the Revision of the guideline on statistical priniples for veterinary clinical trials
26.06.2009
The guideline on statistical principles for veterinary clinical trials was adopted in June 2002. Since then it has been referred to extensively in full application dossiers including clinical
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EMEA: Revised Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance working party (PHVWP-V)
26.06.2009
The mission of the PhVWP-V is to provide advice on the safety of veterinary medicinal products authorised in the European Union and the investigation of adverse drug reactions, to enable effective
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MHRA: Periodic (annual) service fees for medicines licences
26.06.2009
Invoices in respect of the 2009/10 Annual Periodic Fees will be sent on 25 June 2009 to all Product Licence Holders and Marketing Authorisation Holders. ...
Polish Ministry of Health: Regulation project on the readability of the package leaflet of medicinal products
23.06.2009
Polish Ministry of Health: Regulation project on the readability of the package leaflet of medicinal products ...
EMEA: Draft documents for Community Herbal Monograph
23.06.2009
Draft documents for Community Herbal Monograph on Thymi aetheroleum Thymus vulgaris L., aetheroleum (Thyme oil) ...
European Commission: Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declarati
23.06.2009
The Clinical Trials Directive provides a regime of authorisation of the NCA, notification of substantial amendments, and declaration of the end of the trial, and exhaustively harmonises these
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