South korea’s MFDS announces revision of Standards and Specifications for Health Functional Food on functional ingredients
The revision strengthens safety management standards for 8 functional ingredients.
Australia’s TGA Medical Device Reform to reclassify certain medical devices
TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
Anvisa publishes new Technovigilance Manual 2021
The new Technovigilance Manual improves health regulation to meet the challenges posed by new technologies and the speed with which reality is changing.
WHO approves emergency use of CoronaVac, Butantan Institute’s vaccine against Covid-19
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Anvisa approves clinical study with advanced therapy product against Covid-19
Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
Guidebook on Requesting Emergency Use of Drugs for Covid-19
The guideline describes the minimum technical requirements to be presented by the companies for temporary Authorization for Emergency Use of drugs for Covid-19.