Government body

Tasks and responsibilities

National

Ministry of Health, Welfare and Sport (VWS)

• grants licences for the performance of animal experiments
• grants (via Farmatec) licences for the production, packaging, approval for release, release and distribution of medicinal products

Ministry of Infrastructure and the Environment (I and M)

• the competent authority for the granting of licences for the creation of and working with genetically modified organisms (GMOs) (through the GMO Department and the Netherlands Commission on Genetic Modification [COGEM])

Ministry of Economic Affairs

• grants licences for the genetic modification of animals (recommendations from the Commission on Biotechnology in Animals [CBD]). The Food and Consumer Product Safety Authority (nVWA) supervises compliance with the conditions and limitations associated with the granted licence

Dutch Health Care Inspectorate (IGZ) 1-1-2012

(Formerly: New Food and Consumer Product Safety Authority (nVWA))

• supervises animal experiments and the implementation of Good Laboratory Practice (GLP) by Dutch research institutes (the European Medicines Agency [EMA] coordinates the GLP inspections during the authorisation procedure for medicinal products that are authorised according to the Centralised Procedure [CP])

Dutch Health Care Inspectorate (IGZ)

• forms (together with the nVWA) the Public Health Supervisory Service
• supervises the production and import (from non-EU countries) of medicinal products for clinical research and supervises compliance with the Dutch Medical Research Involving Human Subjects Act (WMO)
• carries out inspections to verify whether clinical studies are carried out in accordance with the principles of Good Clinical Practice (GCP)
• tests whether the statutory criteria, including the requirements with respect to Good Manufacturing Practice (GMP), are fulfilled

Medicines Evaluation Board (MEB)

• is responsible for the approval (i.e. marketing authorisation) of medicinal products in the Netherlands
• issues scientific recommendations to pharmaceutical companies during the developmental phase of a medicinal product

The National Institute for Public Health and the Environment (RIVM)

• plays an important role in authorisation, monitoring and release of medicinal products in the Netherlands and Europe.
• tests the quality and safety of medicinal products or vaccines based on laboratory and animal studies.
• undertakes periodic analytical research and structural batch checks of medicinal products to monitor whether medicinal products continuously comply with authorised specifications
• makes recommendations on European guidelines regarding authorisation of medicinal products
• analyses problems with medicinal products, for instance illegal products, fake products and inferior nutritional supplements
• develops models and alternatives for animal testing

Animal Experiment Committee (DEC)

• assesses research protocols in which experimental animals will be used

Central Committee on Animal Experiments (CCD)

• functions as an appeals body in the event of a negative recommendation from the DEC and advises the Minister of Health, Welfare and Sport with respect to the recognition of animal experiment committees

Central Committee on Research Involving Human Subjects (CCMO)

• safeguards the protection of study subjects involved in medical research
• assesses, for example, study protocols in which gene therapy, xenotransplantation or research with substances that fall under the Opium Act are involved, studies concerning (somatic) cell therapy, vaccine development, anti-sense oligonucleotides and interference RNA. Other study protocols are assessed by the Medical Ethics Committees (METC’s).

Serious adverse events that occur during the use of non-authorised medicinal products in clinical research must be reported to the CCMO, METC and MEB.

Medical Ethics Committees (METC’s)

• assess protocols for medical research in humans against the statutory requirements

Gene Therapy Office

• functions as a government contact point for gene therapy
• receives (combined) applications for consent, amendments, notifications and reports; streamlines the handling, communicates the decisions to the applicant and serves as an information point

Before gene therapy research can start, permission is needed from the CCMO, the Ministry of Housing, Spatial Planning and the Environment, the GMO Department (advised in this by the COGEM) and the sector FMT of IGZ (advised in this by RIVM).
The Gene Therapy Office is responsible for the harmonisation and implementation of the various laws by the stated bodies.

European bodies

European Commission (EC)

• the EC has the right to propose legislation and draws up concept regulations
• grants marketing authorisation for products for which a marketing authorisation application has been submitted to EMA

European Medicines Agency - (EMA)

• advises the EC about whether or not to issue a market authorisation
• issues, as does the MEB, scientific recommendations to pharmaceutical companies during the development phase of the medicinal product