Aktualności
EMEA: Draft Community herbal monogaph: Echinaceae purpureae radix
04.08.2009
Draft Community herbal monogaph and draft list of references on: Echinaceae purpureae radix Echinacea purpurea (L.) Moench., radix (purple coneflower root) ...
EMEA: Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS)
04.08.2009
Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS) (veterinary medicines) ...
EMEA: Commission regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council
04.08.2009
Commission regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of
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MHRA: Code of practice for pack design for over the counter medicines
03.08.2009
Council Directive 2001/83/EC as amended, requires that marketing authorisation holders (MAH) inform the competent authority of all changes to the labelling which are not connected to changes to
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MHRA: Department of Health consultation on regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine
03.08.2009
A UK-wide consultation on whether practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated was launched on 3 August 2009 by the Department of Health (DH). ...
European Commission: Volume 9B of the Rules Governing Medicinal Products in the European Union: Public consultation on the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use
03.08.2009
The European Commission today launches a public consultation on Volume 9B, the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. Volume 9B has been updated to take account
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EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic
31.07.2009
In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the
Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following
CHMP’s
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EMEA: Concept paper on the need for a guideline on the clinical investigation of specific immunoglobulins
31.07.2009
Due to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data
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FDA: Drug-Induced Liver Injury: Premarketing Clinical Evaluation
31.07.2009
This guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug to cause severe liver injury
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FDA: E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions
31.07.2009
The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15. Biomarker qualification
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