Medical Writing Public Disclosure Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
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Volume 27, Issue 2 - Public Disclosure

Clinical data publication by the EMA: The challenges facing the pharmaceutical industry

Abstract

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised procedure to the EMA. Beforepublication of the documents in scope,companies have to ensure that personal dataof trial participants and personnel as well ascommercially confidential information isprotected. This article describes the challengesfor sponsors to implement and maintainefficient and up-to-date processes that alsotake into account the multitude oftransparency requirements of other channels,such as ClinicalTrials.gov.

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References

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