Research with a medicinal product: extra review competent authority
Research with a medicinal product must undergo an extra, marginal review alongside the review by the reviewing committee (MREC or CCMO).
This extra review only applies to research with a medicinal product submitted according to Directive 2001/20/EC (possible till 31 January 2023).
The extra review is carried out by the competent authority. This is known as a dual reviewing system. Both reviews can take place simultaneously.
The competent authority (CCMO or Ministry of Health, Welfare and Sport) checks if there are ‘motivated objections’ against the study. To do so they use the European adverse reactions database (EudraVigilance) to check if there are any previously reported suspected adverse reactions to the medicinal product which could lead to unacceptable risks to the participating research subject. Furthermore, the CCMO is responsible as competent authority for entering data into the European EudraCT database.
The competent authority issues a ‘No grounds for non-acceptance’ by way of an automatic e-mail. This e-mail is sent to the registered user for the concerned research file in the ToetsingOnline system. A copy of the e-mail is sent to the reviewing committee.