Cross-Atlantic cooperation between regulatory bodies to intensify

The European regulatory body EMEA and the US FDA have said implementation of the EU-FDA confidentiality arrangement was judged by all parties to have been a success and is to be extended.

Following positive feedback from both regulators and industry on the effectiveness of parallel scientific advice at a review meeting in Brussels, it was agreed to extend the process. The FDA said an area of particular benefit is pharmacovigilance, where close collaboration on a number of issues has enhanced patient safety.

The plan is to intensify transatlantic cooperation in the area of medicinal products, with particular focus on vaccines (including preparedness for influenza pandemic), medicines for children, medicines for rare diseases ("orphans"), oncology and pharmacogenomics.

The confidentiality arrangement allows the European Commission/EMEA and the FDA to exchange information as part of their regulatory processes. The types of information covered by the arrangement include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorisation procedures and post-marketing surveillance.

Other areas will be explored in the coming months, such as counterfeit drugs. The FDA said the arrangement had strengthened interactions between the regulatory authorities, "improving the promotion and protection of public health".