last updated 28-04-2025

5.1) national registration procedure

5.1) national registration procedure

Within the Netherlands the College ter Beoordeling van Geneesmiddelen (CBG) is the independent governing body with authority regarding the quality, efficacy and safety of a drug. The organization works closely together with other authorities in the health and pharmaceutical branch, such as the Centrale Commissie Mensgebonden Onderzoek (CCMO) and Zorginstituut  Nederland (ZIN). 

 

CBG 

The CBG is founded in 1963 after the softenon-affaire, where patients of multiple diseases were prescribed thalidomide (softenon). At first thalidomide was thought to be safe for everyone, including pregnant women. However, rather quick it was found out that thalidomide was harmful for unborn babies, resulting in approximately ten thousand affected children. The realization came that some drugs were administered to patients without really having a detailed description of the possible (longterm) effects. It was decided that such things should not happen anymore and thus the government intervened by installing the organization. The CBG was given governing authority on certain issues, working under the responsibility of the ministry of health, wellbeing and sports. Tasks that fall upon the CBG are the registration and documentation of drugs, staying within the confines of the WMO and Gnw. In order for the CBG to do that, some important documents are required. The most essential document for the CBG is the Summary of Product Characteristics (SmPC). This is a summary containing the product characteristics, including dosage, method of administration and possible risks. 

 

CCMO 

As mentioned earlier, the CBG works closely together with the CCMO. The CCMO was founded in 1999 and settled in the Hague. Just like the CBG, the CCMO falls under the responsibility of the ministry of health, wellbeing and sports. The organization has been delegated some tasks to see to its execution. For these tasks, multiple committees are installed. For example, the medical-ethical review committee (METC), which is burdened with the evaluation of the ethical side of clinical trials in humans, but also the application of legislation, determination of safe borders for the dosage, informed consent, and other aspects of the application process. The METC consists of specialists from multiple disciplines: doctor, legal expert, methodologist, ethicist, subject member, pharmacist, and a clinical pharmacologist. Every member offers input regarding their own specific discipline. This input eventually leads to a decision about the application. 

 

In order for the METC to be able to make a decision about the application, a dossier must be handed over, containing the following information: 

  1. Letters 

  1. ABR-form 

  1. Protocol 

  1. All clinical studies 

  1. Methods/biomarkers 

  1. Study design 

  1. Preclinical data 

  1. IB-derisk 

  1. PIF 

  1. Question forms, patient diaries 

  1. Insurance 

  1. Resumés 

  1. Information per involved centrum 

  1. Extra information 

 

WMO 

The legislation does not exactly say what falls and does not fall within the confines of the WMO. This is why the CCMO worked up a definition elaborate said legislation. The definition states that ‘medical-scientific research is research that has the objective to answer a question in the field of disease and health (etiology, pathogenesis, symptoms, diagnostics, prevention, outcome or treatment of disease), via systemically obtaining and analyzing data. The research should aim to contribute to medical knowledge, which also applies to populations outside of the direct research population. 

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