19 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Charting out the plans for 2013, European Medicines Agency will continue to ensure that 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. 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 agency expects a stable total number of applications for human medicines, with 100 applications in 2013. These include some 54 applications for new medicinal products (excluding designated orphan medicines), 20 new orphan medicines and 20 generic applications. Some 10 applications for new veterinary medicines are expected, with three generic applications.
The work program is accompanied by a budget of $306 million (€231.6 million), an increase of 4.1 percent over 2012, which includes fee revenue of $238.2 million (€179.8 million) (3.8 percent increase compared with 2012, this increase is mainly due to inflation) and a European Union (EU) contribution of $51.9 million (€39.2 million).
The main focus of the agency is to ensure that 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. These include a review and optimisation of the scientific processes, including the coordination among the committees, and the continuing implementation of the conflicts of interest policies and their monitoring.
Implementation of new legislation
The agency has endorsed a number of activities for the continued implementation of the 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 comprise: 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 will enter into force in January 2013. The Agency and the NCAs 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 European Commission plans to submit a legal proposal in the first half of 2013 that will represent a major revision of the legal framework for the authorisation of veterinary medicines. The Agency will work closely with the European Commission to provide technical support as it prepares its proposals.
Greater communication and transparency
The Agency will continue to foster its approach to communication and transparency in order to strengthen public confidence in the Agency and the EU system of evaluation and supervision of medicines. The 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.
Increasing efficiency of activities
These activities will be implemented in a difficult economic environment. The pressures on resources of the Agency 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-subsidisation from fee-related activities. A programme aimed at increasing efficiency of operations will continue, and will include implementation of a new information and communication technology (ICT) strategy to support the optimised processes of the Agency.