Non-WMO studies involving medicinal products
Studies regarding the safety of registered medicinal products performed on behalf of the registration authority
Some studies regarding the safety of authorized medicinal products that are performed on behalf of the registration authority do not necessarily meet both criterion 1 and criterion 2 of the WMO
. Nevertheless, these studies still require independent review in accordance with the Dutch Medicines Act. In the case of a multinational safety study, this review is conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which is part of the European Medicines Agency (EMA).
In the case of a national safety study performed at the request of the Dutch Medicines Evaluation Board or MEB (in Dutch: College ter Beoordeling van Geneesmiddelen, or CBG), the review is conducted by the CCMO. In both cases, the reviewing body determines:
- that the study does not promote the use of the medicine (i.e., is not a so-called “seeding trial”),
- whether the payment made to the healthcare professional is reasonable given the associated costs and time required, and
- whether the study is designed to answer the question being addressed.
Other studies involving medicinal products that are initiated and sponsored by the pharmaceutical industry
Non-intervention studies that involve medicinal products and are both initiated and sponsored by the pharmaceutical industry and do not fall under the scope of the WMO or the Dutch Medicines Act—that is, studies that are not requested by the Dutch Medicines Evaluation Board (MEB) or the European Medicines Agency—are reviewed by the so-called non-WMO (nWMO) advisory committee, which reviews the study’s research question, methodology, and ethical aspects. In addition, the nWMO committee reviews whether the study promotes the use of the medicine (i.e., is a seeding trial). For more information, please visit the nWMO website.
More information on seeding trials
For more information on seeding trials, please read the pdf of a short excerpt from the CCMO Annual Report 2002 below. In addition read the editorial Seeding Trial: Just Say "No" by Harold C. Sox and Rennie Drummond (Annals of Internal Medicine 2008, 149(4): 279-280).