On June 18 the US Food and Drug Administration (FDA) issued a press release to announce the expansion of the authority's cooperation with the European Commission (EC) and the European Medicines Agency (EMEA).

With the cooperation the organisations basically intend to reduce regulatory burden and costs as well as to speed up time to market for innovative products. In addition the authorities announced to share important safety information about medicinal products.

According to the press release, it was also agreed to work together "in the areas of pediatrics and medicinal products for rare diseases ("orphan drugs"). Furthermore, scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans. Based upon the newly adopted pediatric legislation in the EU, a "Principles of Interactions" document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized (http://www.fda.gov/oia/pediatricsIP.htm)."

With regard to the cooperation the release also refers to a revision of an "Implementation Plan on transatlantic medicines regulatory cooperation … to describe under what circumstances information will be shared among the parties (http://www.fda.gov/oia/Impplan.htm)." Other areas of discussed cooperation opportunities also include medical devices regulations.

Source: FDA Press Release
 
Prepared by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)