Depending on the characteristics and mode of administration of the medicinal product, it is possible that the GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs do not require an authorisation under the deliberate release frameworks (Directive 2001/18/EC – Part B). When there is no possible release of the GMO in the environment that may confer a risk to human health or the environment (e.g. in case of GM medication taken at home, no risk of shedding, spreading,…), or if proper management procedures and/or working practices are taken to prevent any possible release conferring a risk, then a ‘contained use’ procedure will generally be sufficient. However, if there is a probability of possible release that may confer a risk to human health or the environment which cannot be avoided by proper management procedures or working practices, a notification under ‘deliberate release’ is also required.
If the framework to be followed is not clear to the applicant, it is strongly advised to request a national scientific-technical advice (STA) from the Federal Agency for Medicines and Health Products (FAMHP) prior to the submission of the clinical trial application.
Contained use (Directive 2009/41/EC)
In order to obtain authorisations under the contained use framework, a biosafety dossier should be submitted according to the Regional Decrees transposing Directive 2009/41/EC. Depending on the risk level of the contained use, a simple notification or a prior written authorization from the regional competent authority will be needed. The scientific evaluation is conducted by the SBB for all three Regions.
In case of a CTA following only the GMO contained use procedure, the SBB is the contact point for the submission of the application and to address questions related to the dossier submitted in the framework of 2009/41/EC.
Deliberate release (Directive 2001/18/EC – Part B)
The deliberate release of a GMO into the environment is regulated at the federal level. In order to obtain an authorisation under the ‘deliberate release procedure‘, an application is submitted to the FAMHP. The application will be evaluated by the Belgian Biosafety advisory Council which transmits its advice to the FAMHP.
An application for an authorisation under the ‘deliberate release procedure‘ does not exempt to apply a dossier according to the Regional Decrees transposing Directive 2009/41/EC on the contained use (CU) of GMO's and/or pathogen organisms. It will need to cover all the related contained use activities (e.g. storage and handling of medication, biological samples, hospital rooms, waste disposal).
Timeline of the submission of the applications for authorisation
The applications to seek authorization under clinical trials and under GMO frameworks can be submitted in parallel (i.e. the sponsor should apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).
Additional information can be found at:
- www.biosafety.be/GT/Regulatory/Docs_guidelines/ 2015_07_10_Overview_Application_clin_trials %20WIV-ISP_41_SBB_15_0473.pdf
Application forms to seek authorisation for the GMO aspects
In Flemish region: https://www.biosafety.be/content/contained-use-gmos-andor-pathogens-notifi cation-procedure-flemish-region
In Walloon Region: https://www.biosafety.be/content/contained-use-gmos-andor-pathogens-notifi cation-procedure-wallonia
In Brussels Region: https://www.biosafety.be/content/contained-use-gmos-andor-pathogens-notifi cation-procedure-brussels-capital-region
A public consultation (i.e. a process where information for the public is made available on a publicly consultable and dedicated website) is conducted within the context of the ‘deliberate release’ framework (Directive 2001/18/EC) and lasts 30 days. The public consultation starts within 5 days following the acknowledgement of receipt of the application by the FAMPH and is included in the legal timeline of 90 days that also includes a formal consultation of the Biosafety Advisory Council and the subsequent formal decision. Under the framework of the regional decrees implementing Directive 2009/41/EC, the biosafety dossier comprises a public part, which is not made available on a public website.
National authorities involved
Authorization of clinical trials:
Federal Agency for Medicines and Health Products (FAMHP)
Research and development department,
Eurostation II, 8th floor, Place Victor Horta 40 bte 40, 1060, Brussels
Authorisation of GMO aspects:
STA (Scientific-Technical Advice unit) of the national Innovation Office at the FAMHP: advisory body.
Eurostation II, 8th floor, Place Victor Horta 40 bte 40, 1060 Brussels
SBB: It is involved in the scientific evaluation of clinical trials regulated under the ‘contained use’ framework. It is the point of contact for the submission of the application and/or queries regarding the dossier submitted under the contained use framework.
Scientific Institute of Public health (WIV-ISP)
Biosafety and Biotechnology Unit (SBB)
Rue Juliette Wytsmanstraat,14, 1050 Brussels
Belgian Biosafety Advisory Council: it is an advisory body involved in the scientific evaluation of GMO clinical trials regulated under the ‘deliberate release’ framework. (www.bio-council.be)
(Last reviewed by the Competent Authority: December 2017)