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EMA/HMA set drug application guidance

The European Medicines Agency and Heads of Medicines Agencies have released draft guidance detailing what information included in marketing authorisation applications for drugs can be released

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released draft guidance detailing what information included in marketing authorisation applications companies file for new drugs can be released.

The guidance defines what is commercially confidential information and personal data, with this information to remain protected.

The agencies said the measures are to make application dossiers 'more transparent' and to address requests from members of the public in a more efficient manner. Non-protected information is to become available once a marketing authoristation has been granted.

A consultation period for the draft measures is currently ongoing, with deadline for comments of September 1, 2011.

The EMA said: "The Agency and the HMA are particularly interested in receiving comments on the criteria for the release or protection of personal data, whether contractual arrangements between companies need to be maintained as confidential, and how to address the personal security of individuals involved in studies using animals."

Stakeholders are also invited to share ideas on how to make requests for information easier.

Following the consultation period, the EMA and the HMA will assess all comments received before completing a final version of the guidance document.

The EMA has the full draft guidance available for download.

Comments should be sent to hma-ematransparencyconsultation@ema.europa.eu

2nd June 2011

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