The European Medicines Agency thanks the Pharmacovigilance Working Party (PhVWP) for its work over the past 17 years, following its final meeting last week.
The Working Party, which existed since the Agency’s establishment in 1995, was responsible for providing advice on the safety of medicines and on the investigation of adverse reactions associated with medicines authorised in the European Union (EU). It made an important contribution to the safety-monitoring of medicines and public health across the EU.
The PhVWP had two main roles:
– reporting to the Committee for Medicinal Products for Human Use (CHMP) on centrally authorised medicines and on nationally authorised medicines referred to the Agency. This enabled the CHMP to effectively identify, assess and manage risk at any phase in the lifecycle of a medicine;
– reporting to medicines regulatory authorities in EU Member States on nationally authorised medicines not subject to a referral procedure. For these medicines, the PhVWP acted as a discussion platform for the Member States. Its recommendations, including any recommendations for regulatory action, were not legally binding on the Member States.
Starting in September 2009, the PhVWP published a report after each plenary meeting, summarising the main recommendations issued by the Working Party on nationally authorised medicines. The final report, from the July 2012 meeting, has been published today.
The new Pharmacovigilance Risk Assessment Committee (PRAC) will play a key role in overseeing the safety of medicines in the EU from now on. The establishment of PRAC is one of the main deliverables of the new pharmacovigilance legislation, which came into operation on 2 July 2012.