by, Simon Ruini
13 March 2013
The European Medicines Agency (EMA) has just released the work program for 2013.
The executive director Guido Rasi stated that the Agency will pursue the following priority areas, in an order of relevance that he has not assigned, but that Pharma Design interprets as likely:
- Continuing to ensure that assessment activities are conducted to the highest levels of quality and of regulatory and scientific consistency.
- Continuing to prepare for the implementation of the pharmacovigilance legislation, depending on resources.
- Continuing to prepare for the implementation of the falsified-medicines legislation.
- Preparing for the outcome of the European Commission’s impact assessment on revision of the veterinary-medicines legislation.
- Further developing the communication and transparency activities of the Agency.
The European Agency also presents some results and performance indicators in strategic areas like
Addressing Public Health, Facilitating Access to Medicines, Optimising Safe and Rational Use of Medicines and Optimising the Effectiveness and the Agency itself. Here are some interesting figures we have extrapolated from the paper.
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Finally, as a result of the implementation of the new Pharmacovigilance Regulation in 2013 the Agency expects a considerable reduction in Type II and Type IA/IB variations.
The full document is available here.