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16 June 2008
Public consultation (MLX 350): Amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements
MLX350 seeks your views on amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements.
16 June 2008
MHRA - Common Inspection Findings
The MHRA has recently published an overview of some common inspection findings and current areas of concern that they have identified during recent inspections. Click on: Common Inspection Findings. Alternatively, go to their Good Pharmacovigilance Practice: News site
16 June 2008
Systematic review: Incidence and nature of in-hospital adverse events
This systematic review attempted to provide insight into the overall incidence, preventability and outcome of adverse events occurring in hospital, and also to add information about location, provider and type of events
15 June 2008
FDA rolls out system to link electronic databases for pharmacovigilance
US health officials have finally unveiled details of the FDA's plan to use the massive database containing information on around 25 million people who get their drugs through Medicare's drug benefit programme, as part of an effort to track postmarket adverse events. Medicare is the US insurance programme for the elderly and disabled.
8 June 2008
Adverse effect information in patient information leaflets in UK is inadequate
According to research published in Drug Safety, patient need on adverse effect information is not being met in terms of the provision of usable information about the likelihood of adverse effects.
22 May 2008
EC Analysis of Responses Received on the PhV Legislative Proposals
The Commission has now released the analysis of the feedback received in response to the consultation on the draft legislative proposals on pharmacovigilance.
22 May 2008
Q&A on Implementation of Vol. 9A Pharmacovigilance
The EMEA has published a Questions and Answers document to address frequently asked implementation questions from stakeholders in relation to Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for Medicinal products for Human Use.
8 May 2008 NEW
Download Drug Analysis Prints (DAPs)
Drug Analysis Prints are currently being updated. New DAPs will start to be published over the coming weeks. These are in a new format and display all the up-to-date suspected adverse reaction data reported to the MHRA. Loading of the full set of DAPs to the website will take place over the coming weeks. If the drug you are interested is not available please contact pharmacovigilanceservice@mhra.gsi.gov.uk
8 May 2008 NEW
