New Regulation on clinical trials

On the 27th of May a new Regulation on clinical trials was published in the European Official Journal.  This new Regulation will replace the national legislation on clinical studies with medicinal products.  In Belgium, this is described in the Law on experiments on the human person.

This new Regulation is published at a moment where there is a decline in the number of clinical trials in Europe. Its goal is to address the shortcomings of the current legislation.

The main principles are :

• A simpler authorisation process : all applications will be submitted and treated through an European Portal site. This site is currently developed by the European Medicines Agency, together with the member states.
• One single decision for each European member state : the current system, that requires a double authorisation by ethics committees and competent authorities, is replaced by one single authorisation
• A common evaluation for multinational trials : the scientific aspects of a clinical trial are assessed by a reporting member state. The report can be commented by all concerned member states. The ethical aspects need to be assessed by each member state separately.
• Straightforward timelines : the new legislation foresees a maximal evaluation timeline of 60 calendar days, to allow for a common assessment by competent authorities and ethics committees. When the timeline has lapsed, the application is considered to approved.
• Harmonised rules for informed consent, also for research on minors and incapacitated subjects. 
• Transparency : all clinical trials must be registered.  A summary of the results is made public  one year after the end of the trial at the latest.  More clarity is created on the confidentiality of data generated in clinical trials

The entry into force of the new legislation depends on the functioning of the European Portal, which needs to be validated, in principle by the end of 2015, by the member states.  A number of other aspects need to be defined at the national level in light of a smooth implementation of the new authorization and surveillance process as described in the Regulation.

The famhp wants to prepare the implementation of this Regulation by mapping the necessary steps and by developing operational plans in collaboration with all concerned stakeholders, and by, where possible, proposing policy options.

To manage and support this process, a steering committee is created, composed of representatives of the different stakeholder groups.  A number of action points was already identified :

- Set up the collaboration model between ethics committees and the famhp
- Establish the Belgian contact point
- Determine the future fees
- Organise the safety surveillance
- Clarify the requirements on confidentiality of clinical trial data
- Determine some national position
- Update the national legislation where needed
- Investigate the feasibility of a national indemnification
- Determine the requirements for inspections on good clinical practices and good manufacturing practices
- Quality assurance of the system in light of the audits by the European Commission

The kick-off meeting of this steering Group is planned on the 5th of June, 2014. 

A regular feedback on the status of the different project teams is foreseen, as well as a mailbox for all specific questions on the Regulation ( – subject line “CT Regulation”).




Last updated on 28/05/2014