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The Dutch medicines regulator, which authorises medicines nationally and, inside the European network, is one of the agencies most often appointed to lead the scientific assessment of new medicines for the whole EU.
New cancer medicines are not licensed nationally in the Netherlands: the CBG's 2025 annual report notes that the EU's centralised procedure is compulsory for them, so the dossier goes to the European Medicines Agency, whose Committee for Medicinal Products for Human Use (CHMP) gives an opinion and the European Commission takes the binding decision. Each member state has one CHMP member and one alternate, and the Dutch members sit in the CBG's agency. For each medicine the CHMP appoints a rapporteur and a co-rapporteur from among the national agencies, who follow the product through its life.
The annual report gives the Netherlands 20 rapporteurships and 3 co-rapporteurships in 2025 (21 and 2 in 2021, 17 and 5 in 2022, 10 and 8 in 2023, 12 and 11 in 2024), and its 23 combined (co-)rapporteurships placed it third among EU and EEA countries that year, behind Germany with 32 and Sweden with 24 and ahead of France with 21. It also took 15 pharmacovigilance rapporteurships at the PRAC. In the same year 104 new medicines were approved through the EMA. The CBG comments on academic oncology research proposals at the request of KWF. Once the Commission has authorised a cancer medicine, whether Dutch patients receive it through their insurance is a separate decision, on advice from the Zorginstituut.
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