On 31 January 2022, the clinical trial regulation (CTR) came into force, since then the BEBO Foundation has been following the rates of the CTR. The Minister of Health, Welfare and Sport has set the rates for the medical-ethical assessment in the Netherlands and can adjust the rates annually.

All rates stated below are exclusive of VAT.

CTR submissions

The applicable national rates can be found here under ‘Rates: assessment of drug research (CTR)’. All submissions that fall under the CTR are invoiced through the CCMO.

IVDR and MDR submissions

The current applicable national rates can be found here under ‘Rates: assessment of medical devices (MDR) and medical devices for in-vitro diagnostics (IVDR)’. Invoicing is done via the BEBO Foundation.

Other research subject to the WMO

To keep things clear, we have not drawn up separate rates for this. For other research subject to the WMO, we use the CTR rate for part 1 in which the Netherlands is a concerned EU Member State (MSC), plus the amount for the assessment of part 2. A distinction is made here between commercial and non-commercial research. The rates can be found here.

Cancellation costs for other research subject to the WMO

If a time slot is reserved for a study at a meeting and the study is moved/cancelled on or after the submission date, you will owe us the full assessment fee.

If the study is moved/cancelled 7 days or later before the submission date, we will charge you 50% of the assessment fee.

Amendments

No distinction is made between amendments to studies under the CTR, clinical trial directive (CTD) or other WMO research. There are three categories of amendments, part I, part II or parts I and II. Which documents fall under Part I and which fall under Part II is made clear here (Part I: Section B-J; Part II: Section K-S). The rates can be found here.

Non-WMO statement

The rate for a non-WMO statement is € 500. If the assessment is very complex and it has to be assessed in a meeting, the rate is € 1000.