Wednesday, March 28, 2012

Euro drug agencies agree on confidential info access



The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a joint guidance document, providing, for the first time, a consistent Europe-wide approach to the identification of commercially-confidential information and personal data in a marketing authorisation (MA) application.
In what the agencies describe as "a major step for transparency," regulatory authorities in the European Economic Area (EEA) will in future apply the same principles to identify which parts of an application dossier can or cannot be released in response to requests. This will apply regardless of whether the product concerned has been authorised using the centralised, mutual recognition or decentralised procedures.

Posted via email from Jack's posterous

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