Aktualności
EMEA: Concept paper on the revision of the guideline on Radiopharmaceuticals based on Monoclonal Antibodies
06.11.2009
The revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies will focus on quality aspects encompassing both monoclonal antibodies and radiopharmaceutical aspects and will
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MHRA: European Commission review of the Clinical Trials Directive
06.11.2009
On 9 October 2009, the Commission published a public consultation document seeking comments on a range of questions posed. To ensure that in coming to a UK position we have taken account of the
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EMEA: Concept paper on the need for revision of the CHMP note for guidance on the clinical development of medicinal products in the treatment of asthma
30.10.2009
The CHMP note for guidance on the clinical investigation of medicinal products in the treatment of
asthma came into operation in May 2003. Since then, it has been proven to be useful for both
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EMEA: EMEA post-authorisation procedural advice has been updated
30.10.2009
This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMEA position on
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HMA: Draft Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure
30.10.2009
These Best Practice Guides are intended to facilitate the practical application of the guidance for the
handling of Mutual Recognition variations outlined in Notice to Applicants, Volume IIA,
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European Commission: Transatlantic Administrative Simplification Action Plan – 2009 implementation report
30.10.2009
Under the auspices of the Transatlantic Economic Council, on 28 November 2007 the
European Commission hosted the Transatlantic Administrative Simplification Workshop
which was co-chaired by the
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MHRA: Over-the-counter cough and cold medicines: Guidance for the introduction of child resistant containers (CRCs)
30.10.2009
In February 2009, the Commission on Human Medicines (CHM) issued advice on over-the-counter cough and cold medicines for children. This included the advice that products containing the specified
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FDA: SPL Standard for Content of Labeling Technical Qs & As
30.10.2009
This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup
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EMEA: Guideline on Summary of Product Characteristics Rev.
23.10.2009
This guideline provides advice on the principles of presenting information in the SmPC. Applicants
should maintain the integrity of each section of the document by only including information in
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EMEA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products in the treatment of depression with regard to treatment resistant depression
23.10.2009
There are new proposals with operationalized criteria for TRD available allowing definition of a
patient population, which suffers from clinically relevant impairment and requires
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