EN PL

News

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). ...

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

26.01.2012
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

19.01.2012
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

19.01.2012
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) ...

EMA: Guideline on the evaluation of anticancer medicinal products in man

19.01.2012
The purpose of this guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective ...

EMA: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

12.01.2012
Guidance on evaluation of medicinal products indicated for the treatment of bacterial infections(CPMP/EWP/558/95 Rev 2) has been adopted. It provides details of requirements for clinical studies ...

EMA: Public consultation opens on the revised guideline on the evaluation of human anticancer medicines

12.01.2012
The European Medicines Agency has launched a public consultation on the revised guideline on the evaluation of human anticancer medicines. The purpose of the guideline is to provide guidance on ...

IPEC: Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients

12.01.2012
This document has been written to provide a tool for those auditing companies involved in the supply chain of pharmaceutical excipients ...

FDA: Use of Histology in Biomarker Qualification Studies

05.01.2012
This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is used as a reference standard. This guidance discusses the processes that should be ...