Clinical Trials Coordination Group Fees for clinical trials submitted under the Clinical Trial Regulation (CTR)

The CTCG “Fees for clinical trials submitted under the Clinical Trial Regulation (CTR)” table provides a country‑by‑country overview of fees linked to applications submitted in CTIS under Regulation (EU) No 536/2014. For each European Union or European Economic Area member state, it includes:

• the national website where detailed fee information and legal bases are published
• the form of proof of payment required for upload in CTIS (for example invoice details, proof of payment or payment commitment letter)
• when fees are expected to be paid (before validation, during validation, after validation, during assessment) and whether payment timing affects procedural timelines
• whether a zero fee, reduced fee or no reduction applies for non‑commercial sponsors
• whether reduced fees apply to low‑interventional clinical trials
• whether fee reductions or non‑invoicing policies apply if an application lapses or is withdrawn at particular stages
• other specific reductions, such as zero fees for orphan‑designated investigational medicinal products or special arrangements for
• safety assessments and inspections.

Examples in the table show that several countries apply zero fees for non‑commercial sponsors (including Estonia, Finland, Hungary, Ireland, Italy, Norway, Portugal and Spain), while others offer reduced fees in defined circumstances, or charge no fees at all for clinical trials (France). Notes at the bottom of the table explain country‑specific arrangements, such as reduced fees in Belgium covering safety assessment, good clinical practice inspections and safety‑monitoring activities, with the remainder covered by a zero‑fee agreement with government.

For sponsors of investigator‑initiated, non‑commercial or low‑interventional clinical trials, this consolidated overview allows quick comparison of national fee approaches, proof‑of‑payment expectations and potential reductions, supporting efficient budgeting and planning of multi‑national submissions in CTIS.