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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 ...

MHRA: FAQs for variations submitted after 1 January 2010

26.02.2010
This document gives answers to frequently asked questions on variations submitted after 1 January 2010. ...

Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008

01.02.2010
The Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination ...

GMP laying down the guidelines for Quality Management System

01.02.2010
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. ...

EDQM: Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopeia Monographers

01.02.2010
To be in line with the revision of the EU Regulation on Variations to marketing applications, the system for revision/renewal of CEPs will change for all requests for revision received from 1st ...

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