On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .
According to this new regulation, Anvisa will approve new clinical trial applications for local clinical studies on new covid-19 vaccines within 72 hours after receiving a complete application from sponsors. Additionally, Anvisa will review and approve the complete registration dossiers for Covid-19 vaccines in 60 days after receiving an application from sponsors.
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
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