Recent articles in the media have once again questioned the reliability of the serological tests bought by the government, in particular the DiaSorin test. The FAMHP is clear: on the basis of current scientific knowledge, this test meets all requirements and can be used without any problems.
Coronavirus – Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19
Because of the benefits to both patients and healthcare professionals, a study on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using molecular detection tests (PCR) was launched on 28 May 2020.
Coronavirus and the fight led by the FAMHP: the FAMHP facilitates and supports the development of COVID-19 treatments and vaccines
Since the start of the coronavirus pandemic, the FAMHP teams have devoted a lot of resources to monitoring and supporting clinical research on COVID-19. Here is an overview of the measures implemented by the FAMHP.
Coronavirus and the fight led by the FAMHP: solutions implemented by the FAMHP in the face of medical equipment shortages
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals facing difficulties with supplies of medical devices. Here is an overview of the measures implemented by the FAMHP.
The Federal Agency for Medicines and Health Products (FAMHP) has authorized the first clinical trial evaluating a vaccine against COVID-19 in Belgium. This is the candidate vaccine from the German biotech firm CureVac.
Because medical devices such as medical gloves, surgical masks, intensive care equipment and other medical equipment play a crucial role within the context of the COVID-19 pandemic, on 24 April 2020, the application date of various provisions of the European Regulation (Regulation 2017/745) on medical devices was postponed until 26 May 2021.
Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic
The national directive published on 07.04.2020 concerning the reprocessing of surgical and FFP2/3 face masks has been updated. This directive aims to guide the validation of the various initiatives being put in place regarding the reuse of surgical masks and personal facial protection.
In order to assist those offering alternative methods of producing medical devices, the FAMHP has developed guidelines which will help guarantee patient safety and the performance of the products used.
Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic
A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.
The FAMHP has been contacted by several companies from which the FAMHP has supposedly ordered medical or laboratory equipment. This is a case of identity theft, whereby FAMHP information is being misappropriated to steal equipment.