FDA, EMEA, EC Extend Regulatory Collaboration Efforts

Rockville, MD (June 18)-The US Food and Drug Administration, the European Commission (EC, Brussels, Belgium), and the European Medicines Agency (EMEA, London, UK) have agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs). These activities will include scientific dialogue on extensions of therapeutic indications and risk-management plans.

According to a prepared statement, the agreement “builds on the achievements in cooperation on vaccines, oncology, and pharmacogenomics” with the objective of “promoting and protecting public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner.”

The European Union recently adopted legislation governing pediatric therapeutics. During a meeting with FDA in mid-June, the EU finalized its  “Principles of Interactions” document, which aims to facilitate timely exchange of scientific information and ethical issues. The meeting also involved a discussion of “upstream regulatory cooperation on new medicines legislation.” Although no details of this discussion were released, the agencies announced plans to hold a meeting on a “Transatlantic Workshop on Administrative Simplification in Medicines in Regulation” to be held November 28 in Brussels.