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

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

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

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

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 ...

EMA: New measures to facilitate conduct of ENCePP studies

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have put in place a new process to facilitate interaction between ENCePP ...

EMA: European Medicines Agency issues revised guidance on genotoxicity testing of medicines

The European Medicines Agency has published a revised guideline on how pharmaceutical companies should test their medicines for damaging effects on the DNA. ...

EMA: Committee on Herbal Medicinal Products approves four-year work programme

The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved a work programme for 2012-2015 with the aim of strengthening the integration of herbal medicines in ...

EMA: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines

Finalising its review of somatropin-containing medicines, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirms that the benefit-risk balance of these ...

GMP: New FDA and EMA Initiative allows mutual Recognition of Inspections

The latest step in the increased collaboration between European authorities (represented by the European Medicines Agency - EMA) and the FDA is about to pave the way for a new relationship leading ...

GMP: IMB publishes Guide on GDP (wholesale distribution)

On 29 September 2011, the Irish Medicines Board (IMB) published the Guide on wholesaling of medicinal products for human use in Ireland. This guidance document covers the wholesale distribution of ...

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