EN PL

EMEA: Experience of the CHMP Peer Review – A tool for quality assurance of the evaluation of new marketing authorization application in the Centralised Procedure.

18.03.2010
The CHMP Peer Review process applies to the initial phase of the assessment of new Marketing Authorisation Application. It is a process by which other members of the CHMP review Rapporteurs’ scientific evaluation , as well as the validity of scientific/regulatory conclusions reached after the first phase of the EU regulatory assessment.