June 2021: European Regulators Mull Ways to Improve Trial Reporting – A TranspariMed Article

The article, European regulators mull ways to improve trial reporting, was published on TranspariMed on June 02, 2021.

The discussions are initiated by the European national regulators, the European Medicines Agency and the European Commission after a letter was sent on behalf of 18 European civil society groups to Heads of Medicines Agencies (HMA), in which HMA was asked to ensure that all national medicines regulators in Europe directly contact all trial sponsors that have left results unreported. This was one of the 4 common standards suggested in this letter.

As a response, HMA mentioned that they are not in a position where the organization can impose standards on the national competent authorities, however, they will reach out to the European Commission and the European Medicines Agency with a view to initiate joint actions to improve clinical trial sponsors’ compliance with CTIMP results reporting requirements.

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