European Medicines Agency focuses on new legislation in 2012 work programme

20/02/2012

European Medicines Agency focuses on new legislation in 2012 work programme

This year, the European Medicines Agency's activities will concentrate on the implementation of the pharmacovigilance legislation and preparations for the new legislation on falsified medicines, according to the work programme 2012, published last week.

The document, adopted by the Agency’s Management Board at its meeting on 15 December 2011, forecasts a stable number of applications for marketing authorisation for human and veterinary medicines in 2012.

It states that the Agency will continue to review its activities and processes so that it can identify areas where efficiency gains, re-allocation of resources and reprioritisation of activities may be possible. This should put the Agency in a position to manage its increased responsibilities with existing resources.

In line with the road map implementation plan, the Agency will strengthen the quality and the regulatory and scientific consistency of its assessment process and its outputs where needed.

The Agency will also increase its levels of transparency, advance its initiatives in the area of communication and interaction with stakeholders, deliver on public-health needs, support the availability of veterinary medicines and support the review of veterinary legislation.

The Agency publishes a work programme every year in English. It will publish the introduction of the 2012 work programme translated into all official European Union languages later in the year.