1. WHO Africa
  2. Health topics
  3. Immunization
  4. African Vaccine Regulatory Forum (AVAREF)
  5. African Vaccine Regulatory Forum (AVAREF) - Domestication of AVAREF Guides and Tools...

Domestication of AVAREF Guides and Tools

To ensure full adoption and use of these tools, in February and May 2019, they were presented to members of the Economic Community of West African States (ECOWAS), the East African Community (EAC), and the Southern Africa Development Community (SADAC), who reviewed and revised them. Following the subsequent unanimous adoption by the AVAREF Assembly of these tools in October 2019, some of these countries quickly adopted the tools, incorporating them into their own national regulatory systems. Some regions also developed regional versions through group reviews, making minor changes for local adoption, thereby ensuring full domestication and use of these tools.

 

Domestication Efforts

 

In May 2019, AVAREF supported the joint Good Clinical Practice (GCP) inspection. The inspection set out to test the AVAREF GCP inspection guide and checklist while promoting a joint inspection as part of harmonization efforts. Guidance was developed for inspectorates to conduct inspections of a clinical trial at any stage. It is expected that the inspection guide and checklist will further help National Regulatory Authorities (NRAs) improve the harmonization of inspection of clinical trials in Africa. The guide was designed to help NRAs ensure that clinical studies can be done on the robust foundation of ethical and scientific integrity of the trial and the data.

The AVAREF GCP inspection guide and accompanying checklist were adopted by the Steering Committee and piloted at a clinical trial site in Gondar, Ethiopia, in June 2019. The clinical inspection was jointly conducted with inspectors and experts from Kenya, Sudan and Uganda, as well as the WHO. The clinical trial application was reviewed and approved by the NRAs and ethics committees (ECs) of Ethiopia, Kenya, Sudan and Uganda.

AVAREF continues to support Regional Economic Communities (RECs) and Member States in implementing regulatory tools. For example, The EAC Medicines Regulatory Harmonization (EAC-MRH) Programme invited AVAREF to a four-day workshop to provide technical support in revising AVAREF’s regulatory tools for adoption in the EAC. The regulatory tools included AVAREF’s clinical trial application form, clinical trial assessment templates (including the non-clinical, quality, statistical, and clinical assessment templates), GCP inspection checklist and GCP inspection guide. Representatives from NRAs and ECs from Burundi, Kenya, South Sudan, Tanzania and Uganda agreed to officially adopt the AVAREF regulatory tools on clinical trial oversight after minor revisions. The representatives also agreed to support neighboring countries to implement the regulatory tools with technical support as required.