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EMA relaxes public access to documents

The European Medicines Agency (EMA) has relaxed its policy on access to documents related to medicines for human and veterinary use

In response to increasing public demand for more openness and transparency, the European Medicines Agency (EMA) has relaxed its policy on access to documents related to medicines for human and veterinary use.

As a result of this new policy, the public will have wider access than ever before to documents held by the Agency. The EMA is keen to stress however, that personal data and commercial confidential information will remain adequately protected. 

The public will now be able to access supplementary information, such as clinical trial reports, which are submitted to the EMA as part of a marketing authorisation application. Should it only be possible to release part of a document (such as in cases where the decision-making process for the application has not been finalised), the Agency will redact the document to protect personal data and commercial confidential information, and release the non-confidential parts. 

"Openness and transparency are enshrined as fundamental values in the Agency's regulatory framework", said Noël Wathion, head of patient health protection at the EMA. 

"They allow our stakeholders to understand the basis for the Agency's scientific decision-making and provide for the basis on which patients and healthcare professionals can have confidence in our opinions and information relating to medicines," he continued.

The new policy will be introduced in to phases, the first of which will deal with the disclosure of documents in response to written requests. The second phase will involve populating the electronic register with those documents held by the Agency and that can be disclosed. 

This output document on the EMA website (pdf), contains a list of all documents which can be disclosed.

2nd December 2010

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