EMA and FDA Extend Confidentiality Arrangements Indefinitely

The European Medicines Agency (EMA) and the US Food and Drug Administration have extended their confidentiality arrangements for human and veterinary medicinal products following the “positive experience” gained since the initial arrangements were signed in 2003. Previously, the arrangements had been renewed in 2005 until 2010, but the latest development will see the cooperation continue indefinitely without the need for further renewal, according to an EMA press statement.

The arrangements allow both agencies to exchange confidential information as part of their regulatory and scientific processes. The types of information covered relate to scientific advice, orphan drug designation, pediatric development, good manufacturing practice (GMP) and good clinical practice, inspection planning and reports, marketing authorization procedures and subsequent changes to the marketing authorizations, together with post-marketing surveillance.

The types of medicines covered are those subject to evaluation or authorized under the centralized procedure, as well as medicines that are authorized at a national level by EU member states and that are subject to official European Community arbitrations and referrals.

Cooperation between the two agencies has been increasing significantly during the past few years. Only last month, the agencies issued a call for candidates to take part in a joint GMP inspection pilot program. In March, the agencies also agreed to accept a single orphan-drug designation annual report.