In brief
On 5 October, the European Medicines Agency (EMA) amended its transparency rules on the publication of information on clinical trials submitted through the Clinical Trials Information System. This adjustment was made at the end of the public consultation, launched between May and June, to record stakeholders’ impressions and opinions a few months after European Regulation no. 536/2014 on clinical trials came into effect.
Key takeaways
The new rules, which will come into force after the implementation of the new public portal in the second quarter of 2024, aim to provide access to clinical trial information to stakeholders in a faster and more efficient manner and ensure an increasing balance between data transparency and the protection of business confidential information. One of the most significant changes is the removal of the deferral mechanism, which previously allowed sponsors of clinical trials to postpone the publication of certain data and documents for up to seven years after the end of the trial, in order to protect personal data and confidential business information.
