TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

26^th May, 2020

TMDA ADOPTS AVAREF GUIDELINES FOR EMERGENCY PREPAREDNESS

1. TMDA has adopted the African Vaccines Regulators Forum (AVAREF) guidelines for emergency preparedness after it has been endorsed by the AVAREF Steering Committee (SC). The guidelines outline amongst others, the guiding principles on planning, undertaking expedited reviews, approvals and oversight of clinical trials for national regulatory authorities (NRAs) and national ethics committees (NECs) to follow during pandemic or epidemic.
2. They further articulate on useful guide to regulators and ethics committees of the Regional Economic Communities (RECs) in Africa and sponsors on the critical elements of emergency preparedness to ensure that ethics and regulatory decisions do not constitute barrier to access, but rather promote public health.
3. Domestication and ultimately implementation of these guidelines will facilitate compliance of all stakeholders including principal investigators and sponsors with the ethics and regulatory requirements in the review and approval of clinical trials of medicines and vaccines in Tanzania. TMDA is currently domesticating these guidelines into its regulatory framework pursuant to the Tanzania Medicines and Medical Devices Act, Cap 219 and Tanzania Medicines and Medical Devices (Clinical Trials Control) Regulations, 2013 (GN 53).
4. The adopted AVAREF Strategy and Guidance for Emergency Preparedness can be found here. Here.
5. All comments should be sent through the address below as follows: