You will find frequently asked questions about the Assessment Framework for non-WMO research and their answers on this page. If your question is not answered here, you can contact us.

General information about research

Research falls under the WMO if the following two conditions are met:

  • there is medical research;


  • the test subjects are subjected to extra actions in relation to the standard of care process, and / or a test behavior is imposed on the test subject (e.g. assignment to a specific treatment based on randomization).

All medical studies and investigations that do not fall under the “WMO” Act can be classified as nWMO investigations. For example, observational (non-interventional) research, retrospective database research, non-direct patient-related research (e.g. research from a biobank).

The Assessment Framework currently only applies to (medical scientific) nWMO studies that are initiated and / or financed by pharmaceutical companies. Pharmaco-economic research with a view to the (continuation of) financing of medicines also does not need to be tested.

No, unfortunately this misinterpretation is often used in the media. Phase IV describes drug research that is conducted within registered indication for the drug. Phase IV research can fall under the WMO (if it meets the two criteria from question 1) or outside the WMO.

However, all phase 1, phase 2 and phase 3 studies are by definition subject to WMO.

Studies that fall under the WMO must meet all the requirements set by the Wet Medisch-wetenschappelijk Onderzoek bij Mensen WMO (Medical Research involving Human Subjects Act). In the case of drug research, these are also the quality requirements of Good Clinical Practice (GCP). For studies that do not meet the conditions for research subject to WMO (see above), there are limited legal quality requirements (the most important of which can be found in the Kwaliteitswet Zorginstellingen (Healthcare Institutions Quality Act) and the Wet op de Geneeskundige Behandelovereenkomst (Medical Treatment Agreement Act). In addition, there are the Gedragscodes Goed Gedrag (Gezondheidsonderzoek) en Goed Gebruik (Good Conduct Codes of Conduct ( Health research) and Good Use), on the basis of which the relevant field parties guarantee the integrity and quality of research through self-regulation.

Every research (WMO or nWMO) seeks to answer a scientifically valid question. In the past, some nWMO investigations have been the subject of negative publicity. This concerned studies that were later known to be primarily intended as a marketing tool for the pharmaceutical industry (so-called “seeding trials”). The research-oriented pharmaceutical industry also believes that such research should not be able to take place and is of the opinion that nWMO research must meet objective testing criteria. That is why these companies have contributed to the development of the Assessment Framework for nWMO research. With this Assessment Framework, healthcare providers are guaranteed that research that does not fall under the WMO has also passed the test of relevance, quality, feasibility and the chance of implementation. It has also been tested whether the research complies with the rules for drug advertising and therefore does not involve any undesirable influence on prescription behavior.

Finally, many nWMO studies are aimed at mapping the effects of medical interventions in daily practice (note: such studies are not necessarily nWMO studies, see Question 2). Certainly, with regard to more expensive medicines, it is nowadays often subject to a “provisional reimbursement” regime. During the provisional reimbursement period, the effect of the medication in daily practice will be determined in order to determine whether the provisional reimbursement should be converted into a definitive reimbursement. Because of the availability of resources, (mainly because of their optimal application), it is important for healthcare providers to cooperate in the research.

Questions and answers about the background of the nWMO assessment framework

When the nWMO assessment framework is met, the research can withstand the test of relevance, quality, feasibility and chance of implementation. This is important for the credibility and evidence of the investigation.

The NFU, STZ, NVMETC, Association of Innovative Medicines (pharmaceutical industry) and the ACRON.

The Ministry of Health, Welfare and Sport is in favor of the initiative, because this primarily improves the quality of nWMO studies and is therefore in the interest of patients. By developing and implementing the testing nationwide, with a framework, the testing of medical research becomes more efficient. It also helps minimize the chance of inconsistent judgments by different committees. The Ministry of Health, Welfare and Sport supports the implementation of the nWMO assessment framework by subsidizing this on a project basis.

Given their responsibilities, the IGZ naturally adheres to its own judgment, but is positive about the standardized Assessment Framework for nWMO studies with medicines.

The advantage for (pharmaceutical) companies is that the studies have passed the test of relevance, quality, feasibility and chance of implementation. This is expected to increase the willingness of care providers to participate in such research. As many nWMO studies focus on how effective and / or safe certain medicines are in daily practice, the cooperation of care providers is of great importance. Use of the assessment framework makes it clear that the research does not contain any inadmissible advertising or favor.

A positively assessed protocol from an nWMO study indicates that the test of relevance, quality, feasibility and chance of implementation has been passed. As a result, the starting point for nWMO investigations has become the same as for investigations subject to WMO, which are also tested against these criteria.

Yes, within the European Federation of Pharmaceutical Companies and Industry Associations (EFPIA), the Dutch framework is even considered as an example of self-regulation. Although terms such as nWMO and WMO are typically Dutch, they are aligned with the new regulation of clinical research and the European regulations concerning PRAC (Pharmacovigilance Risk Assessment Committee) studies.

Yes, nWMO studies conducted in the context of pharmacovigilance must meet the criteria of the nWMO assessment framework.

Questions about the application

Pharmaceutical companies that initiate and / or finance (medical scientific) nWMO studies must submit the study to the DCRF for review.

Previously, this was an obligation based on the self-regulation of the stichting Code Geneesmiddelenreclame (CGR). Since 1 January 2015, the CGR has embraced the Assessment Framework for such reviews and the assessment is performed by expert nWMO Advisory Committees. Until July 1, 2015, the companies that had an approved Standard Operating Procedure (SOP) regarding CGR standards were exempted from the mandatory preventive assessment. Since 1 July 2015, the approval of these SOPs has expired and all individual nWMO studies must be reviewed.

There is currently no legal obligation.

Pharmaceutical companies are obliged, as agreed in the covenant for testing nWMO research, to have such studies tested through the Assessment Framework (see also “Handbook” and “Review”. See also question 16.

Investigations commissioned by ZIN, that use the collected data to complete predictive models, so-called pharmacoeconomic studies, do not yet fall within the scope of the Assessment Framework (see also question 2).

Nonetheless, these investigations must meet the standards for reimbursement and personal data protection (see “Standards”). It is also possible that such studies are subject to WMO and should in that case be submitted to a certified METC for assessment.

Patient registries that are set up and / or financed by the (pharmaceutical) industry must be reviewed. Please note: if patients are subject to extra testing or actions compared to standard of care within patient registries, the registry could be fall under the WMO (see Question 2).

From a technical point of view, conducting retrospective research on body materials falls outside the scope of the WMO. Pharmaceutical companies that want to conduct such a study should use the Assessment Framework for this, on the same basis as stated under question 16.

In addition, however, it is common practice that any research that requires material from a biobank is assessed by an ethical review committee. Companies are therefore advised to contact the ethics review committee in these cases.

Yes, all (medical scientific) drug studies set up by pharmaceutical companies that do not fall under the WMO must be tested through the nWMO Assessment Framework. This does not include market research that does not monitor the use of medicines by individual patients, but the position and possibilities for using a medicine in the market. Pharmaco-economic research commissioned by ZIN with a view to the (continuation of) financing of medicines is still outside the scope of the Assessment Framework. Nonetheless, these investigations must meet the standards for reimbursement and personal data protection (see “Standards”).

Practical questions about if you want to get started with the nWMO assessment framework

On you will find all information regarding the nWMO Assessment Framework.

The aim is to provide advice within 6 – 8 weeks. The nWMO Advisory Committees meet on average once a month. If additional questions are asked, the assessment will of course take more time.

Review of a protocol for nWMO research costs € 3250 (excl. VAT). This amount must be paid when the protocol is submitted. If the study is withdrawn during the review, then the full amount of € 3250 (excl. VAT) must still be paid. This also applies if no advice has yet been given.

The amount of time required for submission will depend on the time required to fully complete the Assessment Framework and to send it together with all relevant documents by email ( The assessment by expert nWMO Advisory Committees will take 6-8 weeks. The nWMO Advisory Committee can contact the applicants directly in the interim if this is in the interest of an efficient handling of the application.

You can download the Assessment Framework via the website The document is a Word document. After completing the document completely, it must be saved and then sent together with all relevant documents (as indicated in the Assessment Framework) to

The management of the Assessment Framework nWMO research initiated and / or financed by the pharmaceutical industry has been transferred to the nWMO working group of the DCRF from 1 July 2016. Submission is therefore via The CCMO performs the counter function in cooperation with the DCRF.

The CCMO, in collaboration with the DCRF, acts as a counter for the request for review. The counter checks the application (Assessment Framework including relevant documents) for completeness and then forwards it to one of the participating nWMO Advisory Committees. The Advisory Committee performs out the assessment and advises the applicant. A condition for receiving the advice is that the invoice for the assessment has been paid.

The Advisory Committee is free to contact the applicant directly during the assessment period, as long as the DCRF counter is informed via as a copy holder.

The most important criteria are relevance, quality, feasibility and the chance of implementation. The project is also tested for compliance with the rules for drug advertising and therefore does not involve undesired influencing of prescription behavior. All standards can be read under “Standards” elsewhere on this website.

Any party can issue a complaint regarding any advice that has been issued by sending a motivation and a complaint to the nWMO working group of the DCRF at If desired, the protocol can be resubmitted to one of the other nWMO Advisory Committees.

For the time being, this project has no impact the current procedure for METCs and for non-WMO research in an institution. As soon as something will change here, those involved will be informed in advance.

For the time being, this project has no impact the current procedure for METCs and for non-WMO research in an institution. As soon as something will change here, those involved will be informed in advance.

The procedure for assessing a substantial amendment and further information can be downloaded here.