EU Strengthens Transatlantic Links

The European Union's extensive links with the US FDA and Health Canada have reached a further level of maturity, writes Peter O' Donnell.

The European Union's extensive transatlantic links have reached a further level of maturity with the completion at the end of 2014 of exchanges between the European Medicines Agency and Health Canada.

An official from Health Canada has returned home after two years as a visiting national expert at EMA, where-among other things-he helped prepare the report to the European Commission on the agency’s implementation of pharmacovigilance tasks under the new EU legislation.

At the same time, an EMA official has just completed a 14-month placement with Health Canada, where she contributed to a study on developing medicines for pediatric use, compiled by a 14-member panel of national and international experts with backgrounds in academia, the pharmaceutical industry, regulatory science, and clinical and medical fields. These exchanges come on top of existing regular sharing of information between the two agencies and interactions through topic-based expert ‘clusters’-notably, recently, on orphan drugs and labeling.

The links with Canada complement the far broader and deeper relations that EMA enjoys with the US Food and Drug Administration. These are longstanding, but have recently benefited from new impetus. In this Applied Clinical Trials article, Peter O' Donnell explores this strengthening relationship.