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EMA: Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

03.01.2013
A change to the current ICH S1 guidance on rodent carcinogenicity testing is being considered. The goal of this potential change is to introduce a more comprehensive and integrated approach to ...

EC: Public consultation paper on the regulation on advanced therapy medicinal products

03.01.2013
Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC (hereafter \"Advanced Therapy Regulation\") requires the ...

EMA: Draft European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) reflection paper on collecting data on consumption of antimicrobial agents per animal species, on technical units of measurement and indicators for reporting consumption of a

03.01.2013
The main aim of this reflection paper is to discuss how to establish systems for the collection of reliable and standardised data on consumption of antimicrobial agents by animal species for the ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders

20.12.2012
This document is the revised version of the existing guidance note (CHMP/EWP/3020/03) on lipid-modifying agents. The guideline is intended to provide guidance for the evaluation of medicines in ...

EMA: Nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Draft

20.12.2012
This guideline lays down the non-clinical and clinical requirements for recombinant insulin containing products, including human insulin and insulin analogues, claiming to be similar to another ...

EMA: Guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) revision 4

20.12.2012
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human normal immunoglobulins for intravenous administration ...

EMA: Reflection paper on classification of advanced-therapy medicinal products

20.12.2012
The aim of this reflection paper is to provide guidance on the ATMP classification procedure taking into account the experience gained so far. ...

EMA: Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

20.12.2012
Pleuromutilins are active against Gram-positive bacteria such as streptococci and staphylococci, anaerobic bacteria and Mycoplasmata. They have been used for decades in veterinary medicine for the ...

GMP: New Concept Paper on Annex 17 of the EU GMP Guide

13.12.2012
The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). \"The GMP/GDP Inspectors Working Group recommends that the current version ...

GMP: EMA publishes Concept Paper on the Revision of Annex 15

13.12.2012
In November 2012, the EMA released a Concept Paper of 3 pages on the revision of Annex 15. The introduction presents the reasons why the EMA has planned the revision: significant changes in the ...