Medicines must be effective, safe and of good quality. Here is where RIVM plays a substantial role in providing for admission, control, release of and regulations for medicines, both in the Netherlands and Europe.
Guaranteeing medicines Safeguarding the quality and safety of medicines is a continuous process at the RIVM. The extensive testing of medicine takes place in the registration phase, i.e. the period in which the product is allowed on the market. This is followed by an analytical investigation to see if the medicines meet the registered specifications.
Quality and safety
Medicines do not enter the market until they have been shown to meet strict criteria. These criteria have been established in the European Union guidelines and directives and the European Pharmacopoeia. On basis of the data submitted by the applicant, the RIVM assesses the safety and quality of the medicinal product. These data are evaluated on commission of the Dutch Medicines Evaluation Board. In addition, RIVM performs the batch release on the strength and purity of vaccines and blood products.
Research into poor quality medicines
The IGZ can request the RIVM to investigate problems with medicines that have often found their way into the Dutch market outside the normal procedures. Examples are illegal products, adulterations and poor-quality food supplements.
Focus on alternatives to animal testing
RIVM carries out research on alternative models for testing without the use of experimental animals. These models can be applied to test the safety of medicines, so that animal testing will, in due course, be unnecessary. To facilitate design and interpretion of animal studies, RIVM has developed a special website (interspeciesinfo) containing physiological and anatomical data of humans and animals. Europe
RIVM plays an active role within European institutions associated with admission (EMEA) and control or supervision of safety and quality of medicines (EDQM). The institute makes a substantial contribution to consultations for setting up adequate and effective regulations. |