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EMA: New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document

09.02.2012
The \"Questions & Answers\" part on the EMA website deals with special issues regarding the European marketing authorisation procedure. In irregular intervals, the EMA updates this collection of ...

FDA: FDA Regulation of PET Drug Products Questions and Answers

09.02.2012
This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that ...

Polish Ministry of Health: Regulation of Polish Minister of Health concerning preparations containing narcotic drugs or psychotropic substances.

09.02.2012
Regulation of Polish Minister of Health concerning preparations containing narcotic drugs or psychotropic substances, that might be hold for medical reasons and applied in clinical trials, after ...

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

02.02.2012
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

02.02.2012
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

02.02.2012
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

26.01.2012
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

26.01.2012
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

26.01.2012
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)

26.01.2012
This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2). ...