Useful links about marketing authorisation

Marketing authorization is a critical stage in therapy development and requires accurate evaluation of safety, efficacy and quality before a drug can be authorized for patient use. Regulators review extensive clinical data to ensure that the benefits outweigh the risks. However, challenges such as complex approval processes, regional regulatory differences and the need for ongoing post-marketing surveillance can affect timely patient access.

Scientific Advice

Useful links

  • Lock procedure for expensive medicinal products: infographic of the National Health Care Institute
  • When is registration of a medicine (not) an option? See this registration roadmap (in Dutch) made by Medicijn voor de Maatschappij (Amsterdam UMC)
  • (NL) Beleidsregel voor collegiaal doorleveren vanaf 1 februari 2025: see link to the IGJ website.