The aim of the Gene Therapy Office is to streamline the licensing and permit granting procedures for clinical gene therapy studies in The Netherlands and to provide more insight into the procedures for investigators.
The Gene Therapy Office is primarily a service for professionals conducting clinical gene therapy research involving human subjects. Patients and interested public who want more information about gene therapy and/or participation in clinical trials can contact the Netherlands Society for Gene and Cell Therapy (NVGCT) or the CCMO, where information regarding gene therapy and clinical trials can be found.
Although there are currently various definitions of gene therapy, the Gene Therapy Office understands it to mean the following: 'Clinical research in humans either involving activities with genetically modified organisms (GMO Genetically Modified Organism (Genetically Modified Organism )), or whereby genetically modified cells can be created in the human body, or whereby changes are made to the genetic material of human cells.'
The following bodies can be involved in the assessment of clinical gene therapy research
- The Central Committee on Research involving Human Subjects (CCMO)
- The Ministry of Health, Welfare and Sport (VWS/CBG)
- The Ministry of Infrastructure and Watermanagement (IenW) and the Office for Genetically Modified Organisms (GMO Office), which is responsible for processing permit requests, with additional advice in such processing provided by the Netherlands Commission on Genetic Modification (COGEM)
From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority
From 13 March 2020, research dossiers in the field of gene therapy and medicinal products containing GMOs must be submitted directly to the relevant authority (CCMO as review committee, Ministry o
Requirement applications for deliberate release of gmo’s application for COVID-19 clinical trials COVID-19 is temporarily suspended
On July 17 2020 the European Commission published a regulation that a day later, on 2020, July 18 took effect .