Netherlands Approval Process

Clinical studies on medicinal products must be approved by a certified ethics committee. Whenever clinical studies involve specialised medicinal products such as nucleotides or stem cells they must also be approved by the Dutch competent authority. Usually, approval is granted within four weeks of submitting the application.

Clinical trial start-up time: 2-3 months.

Netherlands Pre-Market Approval Process

To meet the new requirements for clinical study approval for medical devices, it is important to adhere to the appropriate deadlines for submissions. This requires obtaining approval from one of the 24 METCs through on online submission that is prepared by the Sponsor, but completed and submitted by the Principal Investigator. This process is very thorough and requires good and consistent collaboration by all parties involved.