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Belgium: Covid-19: FAMHP adopts new validation procedure for serological tests

On 30 April 2020, the Federal Agency for Medicines and Health Products (FAMHP) established a verification procedure for Covid-19 tests (see our previous blog post Covid-19: measures affecting the life sciences sector (Belgium)).

On 6 September 2020, FAMHP announced that it will gradually return to the conventional way of working (that is, the method being used for other in vitro diagnostic tests), given that clinical laboratories, manufacturers and distributors of serological tests have now adjusted to the pandemic. Therefore, the FAMHP has adopted a new, less time-consuming interim procedure for antibody and antigen tests, laying down specific minimum criteria for such tests to be admitted to the list of recommended tests.

This article was co-authored by Lore Van Espen

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2020 Issue (Thomson Reuters).