EMA publishes background documents on proposed medicines safety research topics and priorities

The European Medicines Agency (EMA) has published background information in relation to 3 medicines safety topics that the European Commission has indicated it may fund research in.
Every year the EMA gives the Commission a list of suggested research priorities on medicine safety based on the considerations of the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Subsequent to EMA’s suggestions of November 2011 an orientation paper published by the Commission in April 2012 (see EU Monitor 13 April http://www.eahp.eu/News/EU-Monitor/EU-Monitor-13-April-2012) indicated 3 EMA subject recommendations will now be considered European research priorities for funding:

  • Long-term safety effects of antipsychotics in patients with dementia;
  • Long-term adverse skeletal effects of bisphosphonates;
  • DNA collection and studies on the genetic causes of adverse drug reactions: angiotensin-converting enzyme inhibitor-related angioedema and statin-induced myopathy.

To support research proposals the EMA has now published background information documents about the 3 medicines safety topics, outlining previous EMA considerations in the areas and why, and in relation to what aspects, EMA consider further research is required.

More information here.