Clinical trials have to
be conducted in accordance with the principles of Good Clinical Practice
and the ethical rules laid down in the Declaration of Helsinki. Prior
to the start of a clinical trial, the opinion (approval) of an independent
Ethics Committee must be obtained (takes approx. 2 weeks).
The Directorate-General of Public Health Protection: Medicinal Products
monitors the implementation of numerous provisions of the Medicines
Act and Royal Decrees. National legislation relating to clinical trials
will be supplemented at some time in 2004 when the new EU Clinical
Trials Directive 2001/20/EC is implemented. A Clinical Trial Authorisation
from the regulatory authority will then be required before a clinical
trial can commence. Overall approval time should be 2 - 3 weeks. Until
May 2004 the authorities need only be notified of the trial.
 Health
Care System |
| Belgium's health care
system combines official and private health care providers.
There is a general social security system, as well as optional
additional private insurance. |
|
BELGIUM
