Scientific and regulatory support

AVAREF provides scientific and regulatory support to medicines, vaccines, and health product developers and sponsors in the conduct of clinical trials that involve African countries. Through scientific advice meetings and multi-country joint reviews, AVAREF facilitates early dialogue between regulators and developers to ensure that studies are well designed, aligned with ethical and scientific requirements, and have clear pathways to market

Secretariat coordination

The Secretariat coordinates its pool of expert reviewers (selected based on therapeutic area, stage of development, and country participation) to ensure efficient, high-quality, and timely assessments. 

AVAREF Support

AVAREF also supports facilitated registration of vaccines and essential medicines in the context of public-health emergencies or outbreaks. 

AVAREF provides scientific and regulatory support to medicines, vaccines, and health product developers and sponsors conducting clinical trials involving African countries.

Through scientific advice meetings and multi-country joint reviews, AVAREF enables early dialogue between regulators and developers to ensure that studies are well designed, ethically sound, regionally relevant, and aligned with clear pathways to authorization and access.

The Secretariat coordinates a continental pool of expert reviewers—selected based on therapeutic area, development stage, and participating countries—to ensure efficient, high-quality, and timely assessments.

AVAREF also supports facilitated registration of vaccines and essential medicines in the context of public-health emergencies or outbreaks.


Eligibility for Joint Review

To be considered for a joint review, a candidate medical product should be of high public-health value for African countries and meet one or more of the following criteria:

  • Addresses a neglected tropical disease or other highly prevalent / serious disease.
  • Addresses an unmet medical need or offers significant improvement over existing interventions.
  • Involves a novel or advanced technology.
  • Targets a disease declared a Public Health Emergency of International Concern (PHEIC) by WHO.
  • Requested formally by one or more countries requiring regulatory or scientific support.

Other criteria may be considered depending on country needs and the public-health context.

What AVAREF Offers

Clinical Trial Scientific Advice

AVAREF Secretariat convenes experts from African NRAs, NECs, and independent experts to provide advice to Applicants.

Clinical Trial Reviews

AVAREF Secretariat convenes African NRAs, NECs and independent experts and coordinates timely and efficient review of clinical trial applications.

Facilitated Registration of Vaccines (during emergencies)

AVAREF Secretariat convenes African NRAs and coordinates timely and efficient review of data for registration of a medical product.