The European Medicines Agency (EMA) says it is expecting requests for scientific advice from makers of human-use medicines to increase 10% next year.
Also, more scientific advice requests are likely to be made jointly with health technology assessment (HTA) bodies, says the Agency, reporting its work programme and budget for 2012, which have now been adopted by the EMA Management Board.
For next year, the work programme forecasts a stable number of applications for human-use medicines marketing authorisations (MA), at 52 compared with 47 this year, in addition to 13 new orphan drug MAs (the same number as in 2011) and 39 generic applications, compared to 45 this year.
Next year's work programme is accompanied by a budget of 222.5 million euros, which is an increase of 6.5% over 2011 and includes fee revenue of 171 million euros (compared with 161 million euros in 2010), and a European Union (EU) contribution of 51 million euros, up from 28 million euros in 2010. The special orphan medicines fund given by the EU has been increased from 4.9 million euros to 6 million euros, but the Agency's workforce for next year is expected to remain at this year's level, with the staff ceiling fixed at 737.
The 2012 budget and work programme will be driven by an implementation plan for the EU pharmacovigilance legislation, to start next July and which will, it says, take "into account the restricted resources and budget available to the Agency." Activities contributing to public health will be given the highest priority, followed by those aiming to increase transparency and improve communication, followed by simplification measures.
A detailed implementation plan for the new pharmacovigilance legislation will be published on the EMA website in mid-January. The plan foresees the establishment of a new Pharmacovigilance Risk Assessment Committee (PRAC), for which there will be an inaugural meeting next July, followed by the establishment and operation of the revised Coordination Group from September next. The Agency also says it will operate the new "urgent" EU procedure from September, and that it plans to introduce public hearings.
Proposals for a revised policy for the handling of conflicts of interest for scientific committee members, experts and Agency staff are expected to be adopted by the Management Board at its next meeting in March, it adds.
The EMA also notes that the Management Board has endorsed a reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials which are conducted outside the EU/European Economic Area (EEA) and submitted in MA applications to EU regulatory authorities. The paper sets out practical steps to be taken during the evaluation of such applications and when providing advice on such clinical trials in the development phase and, while emphasising the role of international cooperation, it aims to assure that such trials "have been conducted in accordance with GCP and ethical standards equivalent to those applying in the EU.”
As a final step, the reflection paper will be presented to the Head of Medicines Agencies (HMA) for endorsement in February.
The Agency also reports that the Management Board has "welcomed and endorsed" a framework for interaction to ensure the support of healthcare professionals for the Agency's work, "in order to access the best possible independent expertise on the use of human medicines in clinical practice, and to contribute to a more efficient and targeted communication to healthcare professionals."
The framework foresees the transformation of the current Committee for Medicinal Products (CHMP) Working Group with Healthcare Professionals into an Agency working party with links to all scientific committees dealing with human-use medicines.
Finally, the Management Board has initiated discussion on a reflection paper on medicines supply shortages caused by manufacturing/Good Manufacturing Practice (GMP) compliance problems. The paper "summarises the lessons learned from previous crises where the Agency had a supporting or co-ordinating role, and presents short- and mid-term actions that may allow the EU network to prevent, mitigate and manage shortages of important medicines," it says.