|
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, Agriculture and
Innovation (EL&I) |
- 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
|
|
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
|