News

5 November 2008 NEW

A revised version of volume 9A "Pharmacovigilance for medicinal products for human use" has been published for consultation.

The proposed revisions primarily concern Chapter I.7 (additional guidance given on post-authorisation safety studies) and clarifications in response to frequently asked questions, mainly regarding electronic reporting and consumer reports, in chapters I.2, I.4, I.5 and Part III.

26 October 2008 NEW

Public consultation (MLX 350): Amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements

23 October 2008 NEW

Good Pharmacovigilance Practice Guide - First Edition

Medicines and Healthcare products Regulatory Agency (MHRA)

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions. This text complements current legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance.

21 October 2008 NEW

New UK ADR Research Centre set up

Four pharmaceutical companies and the UK Medical Research Council are among the financial supporters of a new centre aimed at reducing the risks of adverse drug effects. The MRC Centre for Drug Safety Science will be based at the University of Liverpool's school of biomedical sciences and will provide training programmes for clinical and non-clinical drug safety scientists. It will be led by director Professor Kevin Park and will also involve researchers at Manchester University. The centre has received £3.7 million in funding from the MRC, and companies supporting the centre include AstraZeneca, Novartis, Pfizer and Merck & Co. Copyright Informa UK Limited 2008.

21 October 2008 NEW

FDA Posts New Drug-Safety Information Web Page

October 16, 2008 - To "improve transparency and communication," the US Food and Drug Administration (FDA) has created a new Web page as a single-access point for a wide variety of drug-safety information targeting healthcare professionals and consumers.