EMA Ends 2012 with a Flourish - and a 4.1% Budget Rise


Applied Clinical Trials

It’s well known that we Europeans do like our vacation time. In most cases, any attempts to curtail it will be resisted in the strongest terms, even in these times of austerity.

But it seems like staff at the European Medicines Agency (EMA) are sending out a clear message by working right up to Christmas, and possibly over the holiday period too. As part of its initiative to increase access to clinical trial data and transparency, it is forming advisory groups in several key areas, and nominations for membership of these groups are due to close on Friday 21 December 2012.

The deadline won’t be extended, according to an EMA spokeswoman, and the groups are due to start work in early 2013. So anybody who is under the mistaken impression Europe shuts down for up to a month from around mid-December needs to think again.

I’ve written an article about this topic for the global news section in the January edition of Applied Clinical Trials, so look out for that report in the New Year.

The Agency also issued an important press release on 18 December, giving details about its work program and budget for 2013. Perhaps the biggest shock is that the EMA’s budget next year will be €231.6 million, representing an increase of 4.1% against 2012. This includes fee revenue of €179.8 million (3.8% increase compared with 2012) and a European Union contribution of €39.2 million.

This budget rise looks certain to raise eyebrows in industry circles, particularly at a time when the rest of us are doing well to maintain our income levels and are having to make sacrifices and cuts. It may be very tough for some people to accept, and maybe this is why the press release was distributed so close to the holidays.

On the plus side, however, the Agency does intend to keep busy in 2013. Its priorities will be to continue to ensure that assessment activities are conducted to the highest scientific levels, to increase efficiency, and to develop initiatives for greater transparency and communication with stakeholders. Other drivers include the continued implementation of the pharmacovigilance legislation and the new falsified medicines legislation.

In 2013, EMA 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 (2012: 52, 13 and 39 respectively). Some 10 applications for new veterinary medicines are expected, with 3 generic applications (2012: 9 and 3 respectively).

To read the full text of the release, click here. Also, for news (also issued on 18 December) about the Agency’s 2013 policy on continued fee reductions for orphan medicinal products, click here.

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