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EMEA: Guideline on the development of medicinal products for the treatment of alcohol dependence

04.03.2010
The aim of this guideline is to provide guidance for clinical studies for drugs developed for the treatment of alcohol dependence ...

EMEA: Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on Haematological malignancies

04.03.2010
The aim of this appendix is to provide guidance on the design of confirmatory in patients with haematological malignancies. ...

EMEA: Draft guideline on Real time Release Testing (formerly Parametric Release) for external consultation

04.03.2010
This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR ...

EMEA: Organization of Heads of Unit meetings

26.02.2010
This Standard Operating Group Procedure describes the organization of Heads of Unit meetings and the preparation of meeting documents. ...

EMEA: Overview of comments to the guideline on the investigation of bioequivalence

26.02.2010
Overview of comments received on draft guideline CPMP/EWP/QWP/1401/98 rev.1 has been published. All comments have been gathered on 248 pages. The document contains explanations for all the changes ...

EMEA: Draft Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus

26.02.2010
This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with diabetes. ...

GMP laying down the guidelines for Quality Management System

26.02.2010
The DG Enterprise and Industry has launched a public consultation on part I chapter 1 of the good manufacturing practices laying down the guidelines on Quality Management System ...