The MHRA perspective on the new Pharmacovigilance Legislation
Good article on Pharmacovigilance of MHRA perceptive by Mick Foy, Group Manager – Vigilance, Intelligence and Research, MHRA, UK. On Regulatory Rapporteur Online – March 2012
Website: http://www.topra.org/
Overview of the article : The introduction of the new pharmacovigilance legislation in July of this year will be the biggest change to medicines legislation since the creation of the current European system in 1995. The background to the forthcoming changes dates back to 2003 when the European Commission decided to undertake an assessment of the pharmacovigilance system. Independent review and public consultation followed, as well as further work at the Commission, the European Medicines Agency (EMA) and EU Member States, resulting in the publication of Regulation (EC) 1235/2010 and Directive 2010/84/EC on 31 December 2010.The overriding purpose of the new package is to strengthen the public health system through better pharmacovigilance. However it also seeks to improve efficiency; employ better decision-making processes; reduce duplication and make better use of IT through the use of centralised systems and standards.
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