EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.
Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms
In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.
Sales of paracetamol remain stable, which is why the restriction of only one box per patient is being lifted. The quotas for pharmaceutical companies and wholesalers have already been abolished. Only the intravenous form remains subject to restriction.
In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
International non-proprietary name (INN) prescriptions: version 8 of the “Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”
The FAMHP's evaluators have finalised version 8 of the note “International non-proprietary name prescriptions – Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”.
Coronavirus: Belgian guideline for the management of clinical trials during the coronavirus pandemic
A national guideline is available to complement European guidelines for the management of clinical trials during the coronavirus pandemic.
Directive on the direct dispensing of medicinal products to patients in the context of clinical trials
Due to the coronavirus problem and potentially overloaded hospitals, it may be difficult or undesirable for a patient participating in a clinical trial to obtain their investigational medicinal product (IMP) at the hospital. The FAMHP provides guidelines on this subject.
Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.
Give us your opinion on genetically modified vaccines against HPV infections (Human Papilloma Virus)
The FPS Public Health and the FAMHP invite you to take part in the public inquiry on a clinical trial with genetically modified vaccines ChAdOx1-HPV and MVA-HPV against HPV infections (Human Papilloma Virus). The public inquiry runs from March 4, 2020 through April 3, 2020.
The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.