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EMA: Draft guideline on pharmaceutical development of medicines for paediatric use

10.01.2013
This guideline is intended to provide additional guidance for the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. This guideline should be ...

EMA: Draft guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

10.01.2013
This guideline applies to all human and veterinary medicinal products, including investigational medicinal products, and all active substances that are intended for manufacture in premises used ...

EMA: Guideline on the investigation of drug interactions

10.01.2013
The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated. This applies to both effects of the medicinal product on other drugs ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3

03.01.2013
The purpose of this document is to recommend international standards for photosafety assessment, and to harmonise such assessments supporting human clinical trials and marketing authorization for ...

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 ...

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