Go to content

Submission and review

Research into gene therapy or with medicinal products containing GMOs must be reviewed by various authorities in the Netherlands:

  • Review by CCMO (as competent review committee)
  • Review by the Minister of Health, Welfare and Sport (VWS) (as competent authority; this role has been delegated to the agency of the Medicines Evaluation Board (aCBG). This requirement is only applicable to mutations, amendments or relevant information of ongoing research with a medicinal product (under outdated legislation).
  • Review by the Ministry of Infrastructure and Water Management (and the Office for Genetically Modified Organisms (GMO Office)(GMO) – GGO in Dutch -, responsible for for processing permit requests). Submissions of new medicinal product research files are subject to CTR and require no additional review.

Review by CCMO

More information on the different types of products within this type of research can be found on the page Research on gene therapy, other products that specifically influence the functioning of the genetic material or a medicinal product with GMO. 

CTR can  extend the review timeline for certain types of research, such as research into gene therapy, with a maximum of 50 days (on top of the timeline of 76 days). The review timeline then amounts to a maximum of 126 days.( for more information, please consult the webpage on assessment timelines under CTR)

Review by competent authority

Amendments or relevant notifications of ongoing research with a medicinal product under WMO-legislation involving gene therapy or research with a GMO medicinal product should also be subject to marginal testing by the competent authority . In the case of research with gene therapy or research with a medicinal product containing a GMO, the Minister of Health, Welfare and Sport is the competent authority. This task has been delegated to the Medicines Evaluation Board (CBG). For more information, see extra review competent authority. For more information please consult Geneesmiddelenonderzoek volgens WMO.

Review by the Ministry of Infrastructure and Water Management (and the Office for Genetically Modified Organisms (GMO Office))

Activities with GMOs require a permit under  the Decree genetically modified organisms environmental management (Besluit genetisch gemodificeerde organismen milieubeheer, in Dutch). The Office for Genetically Modified Organisms (GMO Office) is responsible processing permit requests for activities with GMOs that must be assessed for risks to humans and the environment. This is done by order of the Ministry of Infrastructure and Water Management (IenW), which bears final responsibility for the permits.