Competent or involved institutions
The following institutions are involved in clinical research in the Netherlands:
- Central Committee on Human Research (CCMO)
The CCMO guarantees the protection of test subjects involved in medical scientific research. - Medicines Evaluation Board (MEB)
The MEB is responsible for the authorisation of medicines in the Netherlands. - Medical Research Ethics Committees (MRECs)
MRECs test protocols for medical scientific research in humans to meet legal requirements. A list of approved MRECs can be found on the CCMO website. Some protocols have to be submitted to the CCMO. - Netherlands Pharmacovigilance Centre Lareb
Lareb is the Dutch knowledge centre in the field of drug safety. Healthcare providers and patients can report side effects of registered products to Lareb. - Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)
The CMDh was established for the registration procedure for medicinal products based on a mutual recognition or decentralised procedure. - European Medicines Agency (EMA)
The EMA is responsible for the scientific evaluation of requests for a European Marketing Authorisation (Centralised Procedure) for medicinal products.