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Boost For Transparency As EU Court Backs EMA's Approach To Disclosing Clinical Data

 
• By Vibha Sharma

The EU General Court has dismissed three cases by pharmaceutical companies that wanted to prevent the European Medicines Agency from disclosing certain data about their marketed medicines on the grounds that it would harm their commercial interests. Firms now have a clearer idea of the standards they will need to meet to claim their information is commercially confidential.

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Court endorses EMA's implementation of EU Transparency Regulation • Source: Shutterstock

The European Medicines Agency's ongoing efforts to increase the transparency of its drug evaluation process received a major boost after the EU General Court upheld the agency's approach to deciding on what qualifies as commercially confidential information in relation to an authorized medicine and whether it can be publicly disclosed.

On Feb. 6, the General Court, part of the Court of Justice of the European Union (CJEU), dismissed three cases filed in 2015 against the EMA challenging its decisions to...

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