The Gene Therapy Office was set up as of 1 October 2004 and serves as a central point of contact for the authorization of gene therapy research in the Netherlands.
An assessment of gene therapy research involving human subjects brings together several different dimensions, including genetic modification, environmental aspects and research involving human subjects. Different legal regimes apply to these different dimensions, which are often based on European legislation and regulations. In the case of gene therapy, where these regimes therefore come together, the implementation of the various laws was not well coordinated. For investigators it was also not clear what the responsibilities of the different bodies are, what they decide on, in which cases and why. In short, the procedures were unclear to the investigators and, among other things, this caused unnecessary work and sometimes led to delays in decision making.
Gene Therapy Office – 1 October 2004
Both the investigators and the bodies involved agreed that this was an undesirable situation and they decided to set up a working group to bring about improvements. This working group consisted of representatives of research institutes (Dutch Society for Gene Therapy) and the bodies and ministries involved (Central Committee on Research involving Human Subjects; Netherlands Commission on Genetic Modification; Dutch Health Care Inspectorate; Ministry of Infrastructure and the Environment; Ministry of Health, Welfare and Sport; National Institute for Public Health and the Environment). The task put to the working group was to set up a joint procedure for implementing the assessment in those sub-areas for which there is common ground between the bodies involved. The preconditions were that the procedure (a) focuses primarily on solving existing bottlenecks, (b) remains within the boundaries of existing legislation and regulations, (c) is clear and unequivocal for both the bodies involved and the investigators and (d) causes no delays in the procedures. This led to the official creation of the Gene Therapy Office (Loket Gentherapie) on 1 October 2004.
WMO (Medical Research Involving Human Subjects Act ) – 1 March 2006
On 1 March 2006 the Medical Research Involving Human Subjects Act (WMO) was adapted in order to implement the European Clinical Trials Directive 2001/20/EC. As a result of the new WMO some procedures have been adapted.
IGZ – 1 March 2007
Immunological medicines used in clinical research in humans may only be delivered after they are released by the government. In this way to protect the quality, safety and homogeneity of batches of those medicinal products. This release is a responsibility of the Dutch Health Care Inspectorate (IGZ), but is actually conducted by the National Institute for Public Health and the Environment (RIVM (National Institute for Public Health and the Environment )). Due to the change of the WMO the research dossiers are also evaluated by the Medical Ethics Review Committees (MREC) and the Central Committee on Research Involving Human Subjects (CCMO (Central Committee on Research involving Human Subjects )). The same criteria are used as the RIVM. The release of immunological medicines by the Dutch Health Care will lapse as a result of the new Medicines Act. This means that immunological medicinal products from 1 March 2007 to be used in a clinical study, no longer need to be released by the Health Care Inspectorate.
aCBG – 1 March 2012
As of 1 March 2012 of the tasks of the Ministry of Health, Welfare and Sport (VWS (Ministry of Health, Welfare and Sport )) have been delegated to the Medicines Evaluation Board (MEB (Medicines Evaluation Board )).
CTR (EU/536/2014) in force - Jan. 31, 2022
Since January 31, 2022, the EU Clinical Trial Regulation (CTR) 536/2014 is in force. The CTR aims to harmonize and speed up the approval process for drug research in the EU (European Union) so that new drugs can reach the market faster, allowing patients to benefit from them sooner. To achieve this, the evaluation of drug research becomes a joint responsibility of all EU member states. Since the entry into force of the CTR on Jan. 31, 2022, the Directive 2001/20/EC (CTD) has been repealed. Since the entry into force of the CTR on January 31, 2022, the Directive 2001/20/EC (CTD) has been repealed. There is a three-year transition period from that day for drug studies approved under Directive 2001/20/EC. All necessary information for researchers about the CTR can be found on the CCMO website.