PER Welcomes EMEA Plan

The European Medicines Evaluation Agency has proposed that, within member countries of the Scheme for Mutual Recognition of Evaluation Reports on Pharmaceutical Products (PER), companies using the European Union centralized approval procedure should be permitted to use EMEA opinions and assessment reports adopted by the Committee on Proprietary Medicinal Products.

Companies would transmit the reports, notify the EMEA and undertake to inform non-EU authorities to which they have sent a report of any EU regulatory change which might affect significantly an initial positive assessment and lead to refusal, suspension or withdrawal. Upon "reasoned request" from third countries, the EMEA would check the report's authenticity and any statement relating to authorization status. In return, the PER authorities would provide feedback on the EMEA assessment's impact on their decisions. In order to avoid confusion, non-EU authorities would refrain from requesting any other EMEA internal document before the CPMP report.

The PER Committee welcomed the proposal as "a very positive and significant step towards the facilitation of recognition of European marketing authorization."