On 30 March 2010 was published the new version of the “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)”. More guidance on the way these guidelines will be put into practice in Belgium is now published in circular 575.
The new version of the “Detailled guidance” contains a number of crucial changes, such as round the electronic submission of the applications for clinical trials and round substantial amendments.
For this reason, FAMHP has organised a workshop in June with several stakeholders and gave in October the opportunity to all stakeholders to critically evaluate and comment the future circular.
The final version, taking all comments into account, is now available:
Circular 575 + annexes: Applications for clinical trials and submissions of substantial amendments
Potential questions may be sent to the following Email address : ct.rd@fagg-afmps.be