Medicines Regulators on Both Sides of the Atlantic Confirm Commitment to Cooperation on Medicines

October 7, 2008
Company News Release

The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have affirmed their commitment to regulatory cooperation and to intensifying their interactions in several new areas.

Medicines Regulators on Both Sides of the Atlantic Confirm Commitment to Cooperation on Medicines

The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have affirmed their commitment to regulatory cooperation and to intensifying their interactions in several new areas.

Meeting in London on 30 September and 1 October 2008 for the annual review of cooperative activities undertaken under the scope of their
confidentiality arrangements, the European Union and United States authorities agreed to expand cooperation in the areas of advanced-therapy medicines and nanotechnology-derived medicinal products, as well as on the exchange of pharmacovigilance information. This builds on achievements made previously in areas such as oncology, vaccines, orphan medicines and paediatric medicines.

Notable progress has been made on implementing the Transatlantic Administrative Simplification initiative since its launch in November
2007, particularly in the areas of inspections, qualification of biomarkers, paediatrics and advanced-therapy medicines.

The EU–US confidentiality arrangements on medicines for human use were first signed in September 2003 and extended for a further five years in
September 2005. Similar arrangements covering veterinary medicines, which allow the EC/EMEA and the FDA to exchange confidential information as part of their regulatory processes relating to the veterinary sector, were signed in May 2008.

Having been in place for five years, both sides concur that the transatlantic cooperation activities continue to be successful in protecting and promoting global human and animal health, reducing the regulatory burden and costs so that innovative medicines can be brought
to patients in a timely manner, while also allowing critical safety information about medicines to be shared between the US and EU regulatory authorities.