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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 ...

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 ...

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 ...

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 ...

EMEA: Consolidated EMEA decision on the list of class waivers 2009

29.07.2009
The Paediatric Committee of the European Medicines Agency has given, a positive opinion of its own motion for a review of a class waiver on condition(s), ...

European Commission: Publication of summaries of Community Decisions on marketing authorizations

29.07.2009
The Commission publishes, in the Official Journal of the European Union, summaries of Community Decisions on marketing authorisations. These summaries are usually published on the last Friday of ...

European Commission: EudraLex Volume 10 - Clinical trials guidelines

29.07.2009
The \"Questions and Answers document\" in the EudraLex volume 10 on clinical trials has been revised. ...

European Commission: Contribution submitted in response to the Public Consultation Paper on a Contribution for a future Commission regulation on the format and content for applications and requests for an opinion on a maximum residue limit for a pharmacol

29.07.2009
From 11 May 2009 till 6 July 2009 the Directorate General for Enterprise and Industry invited stakeholders to comment on a contribution to the preparation of a future Commission regulation on the ...

MHRA: MHRA exercise to update product information following European paediatric work-sharing procedures

29.07.2009
Following the announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing fluvastatin where product information has not already ...

EMEA: Concept paper on the need to revise the guideline on the use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use

27.07.2009
The current guideline was prepared at a time when the scientific possibilities for transgenic animals were being investigated and no product had been generated for commercial or clinical trial ...