EMA publishes Presentations on Contractual Agreements in Clinical Trials

The effective negotiation and implementation of contractual agreements remains a key challenge in the conduct of clinical trials. Stakeholders have repeatedly highlighted the lack of dedicated platforms where common issues can be discussed with experts from different stakeholder groups. A first step towards such future dialogue was a webinar organised by the ACT EU Initiative (Accelerating Clinical Trials in the EU) and the EMA, in collaboration with the national medicines regulatory authorities (HMA – Heads of Medicines Agencies), which took place on 16 April 2026.

Contracts & Agreements

One of the measures is the standardisation of contractual terms, particularly for contracts between sponsors and clinical trial sites. In Germany, this cause of delays in the start of trials was identified at an early stage, and under the Medical Research Act (Medizin-Forschungsgesetzes - MFG), the Federal Ministry of Health (Bundesministerium für Gesundheit - BMG) was authorised to establish standard contractual clauses by means of an ordinance. These were published and came into force in 2025. Since mid-December 2025, they must be used in the relevant contracts. 

For further information, the EMA has published the presentations shown during the webinar on 16 April 2026 on the event page.