The European Medicines Agency and the US Food and Drug Administration say they have extended their confidentiality arrangements related to medicinal products for human and veterinary use.
The regulators issued a statement saying that they have taken this step following “the positive experience gained since the initial arrangements were signed in September 2003”. This cooperation “will now continue indefinitely without the need for further renewal”.
The pact allow both agencies to exchange confidential information “as part of their regulatory and scientific processes”. These relate to areas such as orphan drug designation, paediatric development, good manufacturing and clinical practice, as well as inspection planning and reports, marketing authorisation procedures and post-approval surveillance.
