The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.
Further specific drivers include the continued implementation of the pharmacovigilance legislation and the new falsified-medicines legislation, and the planned revision of the veterinary medicines legislation.
In 2013, the EMA expects a stable total number of applications for human medicines, at 100, including about 54 applications for new medicinal products, 20 new orphan medicines and 20 generic applications. About 10 applications for new veterinary medicines are expected, with 3 generic applications.
The EMA’s main focus is to ensure assessment activities are conducted to the highest standards of quality, regulatory and scientific consistency. A number of initiatives are taking place to increase the support to the scientific committees and to further assure the quality and consistency of the agency’s scientific outputs, including a review and optimization of the scientific processes and the continuing implementation of the conflicts of interest policies and their monitoring.
The management board endorsed a number of activities for the continued implementation of legislation that takes into account the agency’s budget constraints, as pharmacovigilance fees are not expected before 2015. Activities that will be implemented in 2013 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.
The falsified-medicines legislation takes effect in January 2013. The EMA and the national competent authorities will work on topics such as the development of the union database, which will contain certificates of good manufacturing practice and good distribution practice from all Member States.
The EMA will continue to foster its approach to communication and transparency to strengthen public confidence in the agency and the EU system of evaluation and supervision of medicines. Publication of the agendas and minutes of all scientific committees’ meetings is planned. Following the successful workshop in November 2012 on access to clinical trial data and transparency, the agency will start a consultation with stakeholders at the beginning of 2013 in order to publish a policy on the release of data from clinical trials in early 2014.
These activities will be implemented in a difficult economic environment. The pressures on resources of the EMA and the network will be further augmented by the need to implement new legislative tasks and the continuous increase in activities for which there is no fee revenue, and which will be partly funded through cross-subsidization from fee-related activities. A program aimed at increasing efficiency of operations will continue, and will include implementation of a new information- and communication-technology (ICT) strategy to support the optimized processes of the agency.