The European Medicines Agency (EMA) has begun a review of its operations and processes, and says it expects this process to result in a “significant” reorganisation of its staff during 2013.
The process will involve major efforts from scientific and support staff across the EMA over the next few months, impacting on the Agency’s ability to contribute to meetings and forums, probably until the spring. It will, therefore in most instances, cancel attendance by its staff, although participation by video- or teleconference may be a feasible alternative, it says.
The EMA will be contacting event organisers directly, and its executive director, Guido Rasi, said he apologised in advance to them for any disappointment this may cause in the months ahead.
“The aim of this exercise is to improve our processes and how best to use our resources, not least to ensure that we are better prepared for future legislative and policy changes,” he said.
The review is focusing on the efficiency of the Agency’s scientific activities and its technology operations in the areas of information and communications. “As part of this process, it will focus on the support provided to the Agency’s scientific committees to help them deliver high-quality, consistent opinions,” it says.
Meantime, the EMA’s Management Board has now adopted the Agency’s work programme and budget for 2013.
The programme expects a stable total number of 100 applications for human-use medicines next year. These include 54 applications for new medicinal products (excluding designated orphan medicines), 20 new orphan medicines and 20 generic applications – in 2012, these totalled 52, 13 and 39, respectively.
The work programme is accompanied by a budget of 231.6 million euros, an increase of 4.1% over 2012. Next year’s budget includes fee revenues of 179.8 million euros, which is 3.8% more than this year – largely as a result of inflation – and a European Union (EU) contribution of 39.2 million euros.
EMA says that its main priorities for next year will be to continue to ensure that its assessment activities are conducted to the highest scientific levels, to increase efficiency in its activities and to develop initiatives for greater transparency and communication with stakeholders. As noted above, a number of initiatives are now underway in these areas, including a review and optimisation of the scientific processes – including the coordination among the committees – and continued implementation of the Agency’s conflicts-of-interest policies and their monitoring.
The Management Board has also endorsed a number of activities for continued implementation of the new pharmacovigilance legislation, which take account of the Agency’s budget constraints, giving that pharmacovigilance fees are not expected before 2015. Activities to be implemented next year include: – collection of key information on medicines, including guidance preparation for patient reporting; – better analysis and understanding of data and information; – regulatory action to safeguard public health, including coordination of pharmacovigilance inspections; and – communication with stakeholders.
Also, the falsified-medicines legislation enters into force in January. EMA and the national competent authorities will work on topics such as development of the European Union (EU) database, which will contain certificates of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) from all EU member states.
As part of its moves to improve communication and transparency, EMA plans to publish the agendas and minutes of all scientific committee meetings. And, at the beginning of next year, it will start a consultation with stakeholders on proposals to publish a policy on the release of data from clinical trials in early 2014.
