The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) have been working together towards achieving greater transparency of their operations and better addressing the increasing requests for information they hold from members of the civil society.
This draft guidance document entitled "Heads of Medicines Agencies/European Medicines Agency guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier - release of information after granting of a marketing authorisation" is presented as a consensus document agreed by the entire Network of Competent Authorities, laying down practical orientations for national and European authorities in regard to requests for access to information contained in marketing authorisation (MA) dossiers.
All stakeholders (including industry, healthcare professionals and patient organisations) are invited to share their views via a public consultation before a final version of the guidance document will be agreed upon. This may be an interesting opportunity for patient associations who are interested and involved in drug development and marketing-authorisation.
The document is available for consultation on the following webpage:
Comments related to this document should be sent before 1st September 2011 to the following mailbox:
CFE will take part in this consultation, but national CF association can reply individually too.
If you have any ideas on the topic we would to happy to hear from you so we can reply in a way reflecting the point of view of as many CF associations as possible.