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EMA to focus on efficiency, transparency and new legislation in 2013

Regulator also plans significant staff reorganisation

The implementation of new legislation, including this month's introduction of new rules on falsified medicines, will form a central strand to the European Medicines Agency's 2013 work programme.

The programme was backed by the EMA's management board last month and will also see the regulator focus on working to become more efficient and transparent.

Clinical trial transparency is particularly high on the agenda, with the EMA working towards a 2014 update to policy on the area following its November workshop on trial transparency.

The EMA is also part-way through putting in place new pharmacovigilance legislation, which EU member states have until the end of this year to implement.

In 2013, the regulator plans to produce new guidance on patient reported outcomes, improve its analysis and understanding of data and information, and increase the coordination of pharmacovigilance inspections.

The EMA said it expects the total number of medicine applications submitted this year to remain relatively stable at around 100, with new 54 new medicinal products (up slightly from the 52 it received in 2012).

Added to this are an expected 20 new orphan drug applications, up from 13 in 2012, and 20 generic drug applications – which would represent a sharp, but not unprecedented, fall from 2012's 39 applications.

To finance its 2013 activities the EMA's budget will increase by 4.1 per cent to €231.6m, an increase that is mainly due to inflation.

EMA plans 'significant' staff reorganisation
The EMA has also began an internal review to see where its operations and processes can be made more efficient.

Signalling the contribution expected from its scientific and support staff, the regulator said the scale of the work would prevent most staff from attending external meetings and forums, probably until March.

The review is expected to lead to a “significant reorganisation” of EMA staff and will focus on the support provided those working with the Agency's scientific committees.

The EMA's executive director Guido Rasi said the aim of the exercise is to improve the regulator's processes and ensure it makes the best use of its resources – “not least to ensure that we are better prepared for future legislative and policy challenges”.

3rd January 2013

From: Regulatory



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