European Medicines Agency disclosure policy on publication of clinical data
23 September 2015Healthcare & Life Sciences Newsletter of the International Law Office
On June 24 2015 the European Medicines Agency delivered an update(1) on the implementation of its policy concerning the publication of clinical data.
The policy(2) (adopted on October 2 2014) enables interested third parties access to clinical reports and individual patient data submitted as part of a marketing authorisation or post-marketing authorisation for an existing centrally authorised medicinal product. Clinical data submitted in accordance with the centralised marketing authorisation procedure for a medicinal product after January 1 2015 can be disseminated to interested third parties. On July 1 2015 the scope of the policy was expanded to include clinical data submitted as part of an application for an extension of a therapeutic indication or a line extension of a centrally authorised medicinal product.
The update provides stakeholders with information concerning procedural requirements and guidance on the redaction of commercially confidential information and the anonymisation of personal data.
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This update was first published in the Healthcare & Life Sciences Newsletter of the International Law Office – www.internationallawoffice.com