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.
In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.
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.
The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
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.
Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.
An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.
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.