GMP: Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment

The EU Commission published a concept paper to extend Directive 2003/94/EC to GMP for APIs. This had already been announced in Directive 2011/62/EU on the prevention of the entry of falsified ...

GMP: Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure

The Guideline on Active Substance Master File Procedure is an important document within the framework of a marketing authorisation. The ASMF describes the quality characteristics of the ...

EMA: Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

This guideline addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug ...

EMA: Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is ...

EMA: Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products

This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of ...

EMA: Draft guideline on the approach to establish a pharmacological acceptable daily intake

This guideline gives advice on when to establish a pharmacological acceptable daily intake and provides guidance on the pharmacological studies and endpoints to be addressed. ...

EMA: Draft guideline on active-substance-master-file procedure (revision 3)

This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2). ...

EMA: Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man

The use of progression-free survival (PFS) or disease-free survival (DFS) as endpoint in clinical efficacy trials presents several methodological issues which need to be addressed prospectively. ...

EMA: Guideline on similar biological medicinal products containing interferon beta

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β) containing medicinal products claiming to be similar to another interferon beta already marketed. ...

EMA: Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis

This guideline replaces the points to consider on the clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs in rheumatoid arthritis (CPMP/EWP/556/95 rev. 1) ...

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