EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms the commitment of regulatory authorities across the European Economic Area (EEA) to extensive transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is authorised.
With the adoption of the initial guidance in 2012, European regulatory authorities agreed for the first time a common and consistent approach to identifying which parts of an application dossier can or cannot be released to the public, regardless of whether the medicine concerned has been authorised using the centralised, mutual-recognition or decentralised procedures…
