As of April 4, 2022, the CCMO’s 2021 Annual Report will be available and presented to the Minister of Health, Welfare and Sport, Ernst Kuipers and the presidents of the Senate and House of Representatives. In the annual report, the CCMO reports on its activities in the past year.
In addition to the introduction of the new legislation for research with medical devices, the MDR (Medical Device Regulation), 2021 was dominated by preparations for the European Medicines Regulation, the CTR (Clinical Trial Regulation) for everyone involved in clinical research. The CCMO pays extra attention to this subject in this annual report. In three interviews, professionals talk about the challenges of the CTR, but also about the opportunities that this regulation offers for clinical research in the Netherlands.
The annual report also provides insight into the legal duties of the CCMO. In addition, important national and international developments of the past year are discussed that have consequences for the Dutch assessment system and the CCMO. The annual report also contains figures and data about the research files that were assessed in 2021 by the recognized medical ethics review committees (MRECs) and the CCMO on the basis of the Medical Research Involving Human Subjects Act (WMO) and the Embryo Act.
Here is a quick link to the Annual Report.