Welcome | News Archive
7 November 2011 NEW
MHRA stop sending ASPRs / ICSRs from literature articles to industry
5 November 2011 NEW
Medical Science Liaison Association (MSLA)
MSLA have launched their website and are planning their inaugural conference on 15th March 2012.
26 October 2011 NEW
MHRA: Public Consultation (MLX375): Consolidation & review of UK medicines legislation
18 October 2011 NEW
MHRA - Drug Safety Update
Latest advice for medicines users
4 October 2011 NEW
MHRA - Annual Report on Devices Adverse Incidents
1 August 2011 NEW
Members of the Royal Pharmaceutical Society have voted in favour of creating a new category of pharmaceutical scientist membership to come into effect from October 2011.
27 July 2011 NEW
European Medicines Agency plans public access to information on side effetcs
22 June 2011 NEW
MHRA Website Survey
22 June 2011 NEW
ABPI Guidance on Management of AEs and PCs from Company Sponsored Websites
22 June 2011 NEW
PMCPA Q & A on 2011 Code
17 June 2011 NEW
European Commission - Update to CT-3 Guidance
17 June 2011 NEW
ABPI - new white paper calling for a new approach to the management of safety data from non-company sponsored websites
22 May 2011 NEW
MHRA - Medicines regulatory news: New Better Regulation of Medicines Initiative (BROMI) process for the submission of National Renewal applications and a new BROMI initiative for national Periodic Safety Updates Reports (PSURs)
9 May 2011 NEW
Updated ABPI Guidance - collection of adverse event reports, the role of the company representative
9 May 2011 NEW
Updated ABPI Guidance - patient safety and pharmacovigilance in patient support programmes
7 May 2011 NEW
Pharma on Twitter
10 April 2011 NEW
EMA - Volume 9A - Questions and answers on implementation
10 April 2011 NEW
MHRA - New learning resource - Understanding and using drug safety information
The MHRA have launched a new pharmacovigilance module aimed at HCPs to increase awareness about drug safety.
5 April 2011 NEW
The PMCPA has issued informal guidance on digital communications.
1 April 2011 NEW
Update from Good PV Practice Committee
30 March 2011 NEW
New IND safety (SAE) rules delayed till September 2011
FDA delays implementation of the new IND rules that were due to start on March 28, 2011. Now deferred till September 29, 2011
3 March 2011 NEW
MHRA - Best Practice in Reporting Individual Case Safety Reports (ICSRs)
10 February 2011 NEW
EudraLex - Volume 1 - Pharmaceutical Legislation Medicinal Products for Human Use
Following adoption by the Council and the European Parliament, the new legislation on pharmacovigilance was published on 31 December 2010 in the Official Journal of the EU. (Directive 2010/84/EU).
10 January 2011 NEW
Europe for Patients
A European Commission Campaign bringing together different policy initiatives that share a common goal, better healthcare for all in Europe.
10 January 2011 NEW
New Directive and Regulation on Pharmacovigilance - published in the EU Official Journal
The final and formal sign-off took place at a further Council meeting on December 15, and the legal texts appeared in the EU's Official Journal on December 31.