Phase I, II, III and IV

The WMO applies to all medical research in which people are subjected to procedures or are required to follow rules of behaviour, irrelevant of whether it applies to phase I, II, III or phase IV research, or whether it is carried out with an authorised or non-authorised product.

Phase IV research with an authorised medicinal product does not always have to be reviewed. If you only use existing patient data for the phase IV study, then it does not fall under the WMO (this is file research). In this case the patient may not be prescribed a different product.

Research with a medicinal product is arranged into the following phases:

  • Phase I: Human pharmacological: First administration in people, generally in a small number of healthy volunteers. Tolerance and safety are observed, generally by increasing the dosage. It also often concerns an evaluation of pharmacodynamics and pharmacokinetics.
  • Phase II:¬†Explorative therapeutic: research into the activity in (a small number of) patients with a particular medical ailment. Verification of the active mechanism in patients or healthy volunteers and the safety when used for a short period of time.
  • Phase III:¬†Confirmative therapeutic: testing the final dosage in a medical practice on its usability and effectiveness in a larger number of patients. Comparing with an existing product or placebo. Safety in the short and longer terms are also observed.
  • Phase IV:¬†Research after authorisation and related to the indication area for which the product is authorised. These types of research are not necessary for authorisation purposes, though are important for optimalisation of the use of the medicinal product.