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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 ...

EMA: New measures to facilitate conduct of ENCePP studies

05.01.2012
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

22.12.2011
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

22.12.2011
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

22.12.2011
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

22.12.2011
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)

22.12.2011
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 ...

MHRA: Public consultation (MLX 363): Fees legislation for 2012

22.12.2011
This consultation seeks your views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homeopathic medicines, and blood ...

EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

15.12.2011
Article 5(10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state ...