The Ombudsman has asked the European Medicines Agency (EMA) for details about its proactive transparency policy concerning clinical trial data for medicines being evaluated for potential EU market authorisation.

Transparent clinical trial data increases the accountability of regulators. It also benefits patients and can foster scientific innovation and help prevent the unnecessary testing of pharmaceutical products.

EMA first enacted a policy of proactive transparency in 2016 but has suspended it since 2018 due to the relocation of staff to the agency’s new premises in Amsterdam and the need to prioritise other tasks during the COVID-19 pandemic.

The agency has announced that it will relaunch its proactive transparency policy in September 2023 for products containing new active substances. However, it has not said how it will deal with clinical data related to evaluation procedures that were completed during the suspension period.

The Ombudsman has sent a series of question to EMA to ask how and when it intends to publish this data, including whether it plans to prioritise certain product areas. She has also asked EMA about its plans for the further expansion of its transparency policy.