• Version
• Download 2841
• File Size 136.78 KB
• File Count 1
• Create Date 7 June 2021
• Last Updated 8 June 2021

African Union and the Africa CDC’s Africa Regulatory Taskforce has endorsed the Emergency Used Authorization for Janssen COVID-19 Vaccine

June 7, 2021 - The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisation’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
In order to properly guide Member States, the Africa Regulatory Taskforce has developed a framework (https://africacdc.org/download/guidance-on-emergency-expedited-regulatoryauthorisation-and-access-to-covid-19-vaccines-in-africa/) for market authorisation of COVID-19 vaccines, which include three scenarios:
• Scenario 1: COVID-19 vaccines that have received WHO Emergency Used Listing /Prequalification (EUL/PQ) approval.
• Scenario 2: COVID-19 vaccines that have received approval from one or several recognized Stringent Regulatory Authorities (SRAs) but not yet through WHO EUL/PQ.
• Scenario 3: COVID-19 vaccines that have received neither of the above.

Attached Files