Rates for reviewing research with a medicinal product and research with a medical device

In the Netherlands, national rates are set for medical-ethical review of research with a medicinal product and research with a medical device.

These are fees for the assessment of clinical trials into:

  • Medicinal products: Research files falling within the scope of the EU Clinical Trial Regulation 536/2014 (CTR) for research with a medicinal product.
  • Medical devices: Research files carried out for conformity purposes, article 62/74.2 of the EU Medical Device Regulation 2017/745 (MDR). For other research files falling within the scope of the MDR (MDR article 74.1 or 82) the fee of the review committee concerned (accredited MREC or CCMO) applies instead of the national fee.

Please note! The rates for the assessment of clinical research with medicinal products and medical devices will apply from 31 January 2022. On this date, the CTR comes into effect as well. During the first year of the CTR, sponsors may opt for assessment of research with a medicinal product under the current legislation and regulations instead of under the CTR. In that case, the fee of the relevant ethics committee (accredited MREC or CCMO) applies. From 31 January 2023, the national rates will apply to all assessments of research with a medicinal product.

Please note! In the course of 2022, national rates will also be set for the assessment of clinical research with in-vitro diagnostic medical devices falling within the scope of the EU In Vitro Diagnostic Regulation 2017/746 (IVDR). These rates will apply from 2023 onwards.

Rates

CCMO collects the fees below even if the sponsor has withdrawn the file during the assessment. No VAT is charged for the assessment.

For assessments conducted under current legislation during the CTR transition year, the fees of the relevant accredited MRECs are charged. These fees are collected by the MREC itself. This applies as well to the assessment of other medical research outside the scope of the CTR or MDR.

Rates for reviewing research with a medicinal product and research with a medical device
Type of assessment Primary assessment for commercial research Primary assessment of non-commercial research Assessment resubmission* commercial research Assessment resubmission* non-commercial research

Low-rate research file**:

  • CTR: part 1: multinational research with the Netherlands as concerned EU Member State (cMS) or additional Member State
  • MDR: national or multinational research with the Netherlands as concerned Member State
€ 4,000 € 1,550 € 2,000 € 775

High-rate research file**:

  • CTR: part 1: National and multinational research with the Netherlands as reporting Member State (rMS)
  • MDR article 78: Coordinated assessment of multinational research with the Netherlands as coordinating Member State
€ 6,000 € 2,500 € 3,000 € 1,250

Research file ‘national section’:

  • CTR: part 2
  • MDR: national documents (article 78(3), second paragraph)
€ 2,000 € 650 € 1,000 € 325

Product information:

  • CTR: IMPD (for each product)
  • MDR: IMDD (for each product)
€ 2,000 € 675 € 1,000 € 350

Substantial amendment 'major':

  • Complex assessment and or assessment of several documents
€ 1,500 € 625 N/A N/A

Substantial amendment 'minor':

  • Simple assessment or assessment of a few pages
  • CTR: part 2
  • MDR: national documents
€ 500 € 245 N/A N/A

Safety assessments:

  • ASR/DSUR with the Netherlands as saMS
€ 2,500 € 835 N/A N/A

Safety assessments:

  • DSUR: research into the product is only carried out in the Netherlands
€ 1,000 € 170 N/A N/A

Safety assessments:

  • DSUR: the Netherlands is no saMS
€ 500 € 170 N/A N/A

* Resubmission means the resubmission of the (entire) file following a previous withdrawal or negative decision. It does not refer to the assessment of the response and/or amended or additional documents in an ongoing review.

** These rates do not apply to IMPD and/or IMDD (re)assessments, for which separate rates are set (see table).

Annual adjustment

The Ministry of Health, Welfare and Sport may adjust the fees annually, coming into force from 1 January of the following year. CCMO will announce the adjustment annually before 1 July of the preceding year.

Other medical research

Separate fees apply to the assessment of other medical research in the Netherlands. These fees differ per review committee (accredited MREC or CCMO).