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EMA Begins Providing Public Access to Clinical Reports

  • November 18, 2016

  • Beginning in October 2016, the European Medicines Agency (EMA) has made a decision to support transparency in clinical trials by giving open access to clinical reports for new medicines for human use authorized in the European Union (EU). EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

    “Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based”, explained EMA’s Executive Director Guido Rasi. “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”

    With the EMA’s new, proactive approach to providing access to the data, increased transparency will allow for:

    – Patients and healthcare professionals to find out more information about the data concerning the approval of medicines they are taking or prescribing

    – Independent re-analysis of data by academics and researchers after a medicine has been approved, thus increasing scientific knowledge, and potentially further informing regulatory decision making in the future

    – Innovation, as the shared knowledge about a medicine helps developers learn from the experience of others and can lead to more efficient medicine development programs.

    To read the full article, click here.

    For more information on DPharm EU, click here.