- In the Netherlands, clinical studies using (specialised) medicinal products must be approved by a certified ethics committee.
- CHDR develops the study protocol, submits it to a certified ethics committee and the competent authority, and communicates with the Dutch regulatory bodies.
- CHDR has an established working relationship with several ethics committees.
- If desired by the sponsor, CHDR can also serve as a legal representative within the EU.
- In most cases, approval can be obtained within four weeks of submitting the application.
In the Netherlands, clinical studies using medicinal products must be approved by a certified ethics committee that reviews the ethical considerations as well as the underlying science. Clinical studies using specialised medicinal products such as nucleotides or stem cells must also be approved by the Dutch competent authority. The Netherlands uses a balanced system for regulating clinical research, ensuring that subjects are fully protected and minimising the need for overregulation. When the protocol itself is clear and to the point, the regulatory procedures can actually be both fast and efficient. In most cases, approval can be obtained within four weeks of submitting the application.
CHDR provides all of the services needed to optimise development and streamline approval of a new protocol. CHDR’s project leaders develop the protocol, submit the protocol to a certified ethics committee and the competent authority, and communicate with the Dutch regulatory bodies. We have an established working relationship with several ethics committees. Several board members of CHDR have served — or currently serve — as board members on the Dutch competent authority. If desired by the sponsor, CHDR can also serve as a legal representative within the EU.
Dutch law has established limits regarding how long the ethics committee and competent authority can take to review a clinical trial application (CTA).
- The competent authority has two weeks to complete their review and issue a ‘statement of no objection’; in the case of specialised medicinal products, an additional 30 days is allowed.
- Approval by the ethics committee should occur within 60 days of receiving the CTA, during which time the ethics committee can request additional information.
- If the CCMO conducts the review, an additional 30 days is allowed.
- With protocols involving xenogenic cell therapy, no time limit is applied to the review process.
Although the review of the CTA (dossier) by the ethics committee can legally take up to 60 days, in most cases CHDR receives full approval within 14 days of the ethics committee meeting. In parallel, the competent authority usually issues their ‘statement of no objection’ within 10 days. Our timelines, therefore, typically look as follows: