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
- The European Medicines Agency (EMA) can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine’s benefits and risks: scientific advice and protocol assistance
- The European Medicines Agency’s scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications.
- The Medicines Evaluation Board (MEB) in the Netherlands provides scientific and regulatory 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.