The European Association for Hospital Pharmacists (EAHP) has accepted an invitation from the European Medicines Agency (EMA) to attend a stakeholder workshop aimed at informing, and gauging views, on a range of current areas of EMA work.
An immediate priority for the EMA is preparing for the implementation of the 2011 European Commission Pharmacovigilance Directive which includes a new pan-European requirement to enable patient reporting of adverse incidents.
The Directive also brings about a new oversight Committee at the EMA called the Pharmacovigilance Risk Assessment Committee (PRAC).
This will have wide responsibilities relating to pharmacovigilance, risk management systems, post-authorisation safety studies, and safety announcements.
It will make recommendations to the Committee for Medicinal Products for Human Use (CHMP), who in turn make recommendations to the European Commission. PRAC will begin holding its meetings in July 2012.
EMA are currently consulting on good pharmacovigilance practice modules with a deadline for responses of 18 April 2012.
EAHP will review and determine if any response from the profession is necessary.
The EAHP Policy Officer has called for views from National Presidents and Delegates in the interim.
Other aspects of regulatory activity presented by EMA at the workshop included:
· the definitions to be used by EMA in relation to biosimilar products;
· the harmonisation of information for healthcare professionals (HCPs) and the public on summary product characteristics (SmPC);
· the EMA’s role in pandemic communication;
· the future development of the EU clinical trials register; and,
· the particular standardised text across Europe for the encouragement of reporting suspected adverse reactions.
Following the presentation of information from EMA at the meeting, EAHP will be responding to EMA on these issues with any relevant views.