Public Citizen Supports European Policy on Publication of Clinical Trials Data

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Public Citizen writes to the European Medicines Agency (EMA), the European Union agency that carries out premarket approval for drugs, to support the EMA’s proposed policy that would provide for the publication of clinical-trial data submitted to the EMA in the future. This policy will enable independent expert groups to review the benefits of and risks of EMA-approved drugs, which are often also approved for marketing in the United States. The proposed policy will promote transparency and the opportunity for independent review, two cornerstones of sound medical research and good regulatory decision-making, while will adequately protecting patient privacy.