EMA road map to prioritise pharmacovigilance
pharmafile | January 28, 2011 | News story | Research and Development, Sales and Marketing | EMA, European Medicines Agency, pharmacovigilance
The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely at its own efficiency.
These are among the key pledges in the regulator’s ‘Road map to 2015’, published this week, as it goes about its work of protecting and promoting public health in the European Union.
It follows on from a similar EMA statement covering 2005-2010, and more meat will be put on the bones in yet another document, called ‘From vision to reality’, which will be published later this year.
At present the EMA’s top three aims are: meeting public health needs, improving access to medicines and optimising their safe use.
In a wide-ranging document that also touches on issues thrown up by globalisation in the pharma sector, EMA says it wants to stimulate medicines development in areas of unmet need or for rare diseases.
As a co-ordinating body, it plans to take a more proactive approach to public health threats where medicines are involved.
On the issue of access, the EMA talks of “addressing the high attrition rate during the medicines-development process” while noting the growing importance of health technology assessment bodies.
And it wants to improve the evidence base in the post-authorisation phase to enable better regulatory decision-making – as well as improving this process “by taking due account of patient experience”.
When it comes to the EMA’s own efficiency going forward, the road map highlights the increasing complexity of its tasks: the Agency is made up of six scientific committees and 35 working parties and other groups to which it provides scientific support.
“A particular challenge in this area relates to the interactions and interdependencies that exist at various levels between these fora,” the EMA says.
It says it will also continue to review the EU regulatory model although there is no suggestion of radical change.
Critics see the process as unduly complex, with obtaining approval in Europe slower than in the US, in part because of the way the European Commission works.
Finally, in a nod to the financial pressures facing all businesses at present, the document states: “The successful delivery of the Agency’s vision is dependent on the availability of the necessary resources.”
Adam Hill
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