NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
the main framework, while research involving in vitro diagnostic devices is mainly governed by the IVDR. In the Netherlands, the Medical Research Involving Human Subjects Act ( Wet medisch-wetenschappelijk onderzoek met mensen , WMO) is the principal law in this field. Notably, for clinical trials using genetically modified organisms (GMOs) the Genetically Modified Organ- isms (Environmental Management) Decree ( Besluit genetisch gemodificeerde organismen milieubeheer ) and Genetically Modified Organisms Order ( Regeling genetisch gemodificeerde organismen ) are relevant. In addition, several other laws, decrees, and regula- tions may also apply, such as the Embryos Act, the Medicines Act, the Decree on Mandatory Insurance for Medical Research Involving Human Subjects 2015, the Regulation on Medical Research Involving Human Subjects, and the Declaration of Helsinki. 2.2 Securing Authorisation to Undertake a Clinical Trial Pharmaceuticals Clinical trials with medicinal products may fall within the scope of CTR, and the WMO. The Centrale Com- missie Mensgebonden Onderzoek (CCMO) is respon- sible for the implementation and oversight of the WMO in the Netherlands. The CCMO also designates the Medical Research Ethics Committees Medisch Ethis- che Toetsingscommissie(s) (MREC) that are authorised to review medical-scientific research involving human subjects. As of 31 January 2023, all new applications for clinical trials with medicinal products must be submitted via the centralised EU portal, the Clinical Trials Informa- tion System (CTIS). The sponsor proposes one mem- ber state to act as the reporting member state. The reporting member state will then carry out a validation of the application. CCMO carries out this procedure in the Netherlands. After the validation procedure is complete, the evaluation of the application is com- menced. This consists of two parts: • Part I concerns an assessment as regards, inter alia:
(a) whether the clinical trial is a low-intervention clinical trial; (b) the anticipated therapeutic and public health benefits; (c) the risks and inconveniences for the subject; and (d) compliance with the relevant requirements concerning: (i) manufacturing and import of investigational medicinal products; and (ii) labelling. • Part II concerns an assessment of the application in relation to, for instance, compliance with the relevant: (a) informed consent requirements; (b) requirements regarding arrangements for rewarding, compensating and recruitment of subjects; and (c) applicable rules for the collection, storage and future use of biological samples of the subject. For both Part I and Part II, the CTR provides strict timelines. Indeed, after an application by the spon- sor, CCMO shall validate the application within ten days. Once the application is validated, CCMO has to provide the assessment report for Part I within 45 days from the validation date. This period can be extended under certain conditions. In terms of Part II, the evaluation report must be submitted within 45 days of validation. The final decision to authorise the clinical trial will have to be made within five days after the conclusion of the assessment period. Medical Devices Article 62 MDR sets out the general rules as regards clinical investigations conducted to demonstrate conformity of devices. Article 70 (1) indicates that the sponsor of a clinical study must submit an application to the member state(s) concerned, accompanied by the documentation, such as (inter alia): (i) an appli- cation form containing a variety of data (eg, name, address, title of the clinical investigation, etc); (ii) an investigator’s brochure containing clinical and non- clinical information on the investigational device; and (iii) the clinical investigational plan setting out the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation.
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