EMA to become more directly involved in pharma research
Draws up a detailed plan
The European Medicines Agency (EMA) has detailed how it might become more involved in pharmaceutical research in future. It has released a detailed plan saying under what circumstances it should become involved in studies and how it should choose projects and avoid conflicts of interest.
Clearly EMA wants to do more and says: ‘Given the agency’s central role…to promote and protect…health, and support its business processes in the evaluation and supervision of medicines, it is essential for EMA to further evolve from a passive bystander to having an active role in important scientific progress, [especially regarding] developing the regulatory framework.’
The Agency noted that the US Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have all ‘integrated regulatory science in their core activities’.
As a result, EMA’s Executive Director will welcome vetted proposals for Agency participation in research, previously assessed by senior staff.
The plan says such work should focus on projects relevant to EMA’s work; the added value a regulator can give the project; and the need for strengthening collaboration with other regulators and bodies, such as the FDA and the World Health Organisation.
It added that selected projects may focus on emerging and innovative sciences – ‘where the regulatory framework requires constant development’; in identifying research priorities in unmet medical needs, including antibiotics, rare diseases, pregnant women and paediatrics; and research regulatory science methodologies.
EMA officials would have to assess the quality and soundness of the research proposal; potential problems regarding confidentiality and access to data; and conflicts of interest. These are particular concerns where a project has clear commercial benefit to one company or consortium.
‘The Agency may well research a safety concern pertaining to a specific medicinal product in the interest of public health, but not contribute towards the development programme of a particular product or pharmaceutical company,’ EMA said.