BRASIL

On March 13, the National Health Surveillance Agency (Anvisa), issued Resolution RDC No. 346, which sets extraordinary and temporary criteria and procedures governing the certification of good manufacturing practices applicable to the registration of active pharmaceutical ingredients, medicines and health products. The measure comes as a consequence of the international public health emergency prompted by COVID-19 and will be in force until September 10, 2020.

The resolution applies to products intended to control, diagnose, prevent or treat health conditions caused by COVID-19. It also applies to essential products needed to protect life, whose availability is threatened by the shortage (imminent or otherwise current) in the national market because of reasons related to the virus.