Anvisa has released the Guide no. 42/2020 that describes Anvisa’s minimum and current recommendations regarding the data and information necessary to support the issuance of an Emergency and Temporary Use Authorization in Brazil for an experimental vaccine to prevent Covid-19.
This Guide remains in force only during the public health emergency related to COVID-19.
ANVISA’s Analysis of the Submission
To grant the temporary authorization, Anvisa will analyze case by case the data from non-clinical and clinical studies, quality, good manufacturing practices, monitoring and control strategies, provisional results of clinical trials, among other scientific evidence. In addition, the company must present information that proves that the manufacture and stability are adequate to ensure the quality of the vaccine.
The submission must be made by the Covid-19 vaccine developer company, which must have a Company Operating License (AFE) issued by Anvisa with the activity of manufacturing or importing drugs.
The request for temporary authorization for emergency use, on an experimental basis, must be submitted to Anvisa through a specific subject code, to which must be attached the reports of available data on quality, safety and efficacy of the vaccine, in addition to a conclusive report that shows to be favorable to the benefit-risk ratio for the emergency use of the vaccine.
Before the formal submission of the request for temporary authorization, the applicant must schedule a meeting of pre-submission with Anvisa, through the General Management of Medicines and Biological Products (GGMED).
The vaccine must have a Drugs Clinical Development Dossier (DDCM) analized by Anvisa and the phase 3 clinical trial at least in progress and under way in Brazil.
The applicant shall undertake to complete the development of the vaccine, present and discuss the results with Anvisa and request your sanitary registration, as long as the requirements are met regulations, according to the sanitary legislation in force.
About Global Regulatory Partners
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. To learn more, please contact us at email@example.com