To make potential Ebola therapies and vaccines available as quickly as possible, the ninth African Vaccine Regulatory Forum (AVAREF), which was concluded at the weekend in Pretoria, South Africa, has agreed on a collaborative mechanism for fast-tracking approvals for clinical trials and registration of these products in the affected countries.
The mechanism, according a statement from the World Health Organisation (WHO), would cover:
. Clear pathways and timelines for expedited ethical and regulatory review of clinical trial applications and approval of products;
.Agreement on timelines and joint safety and efficacy assessments of the new products to fast-track national registration;
.Endorsement of a panel of safety experts for expedited review of safety data of new products with relevant communication to National Regulatory Authorities (NRAs); and
.Technical assistance from the WHO to facilitate these processes.
The Pretoria meeting brought together public health officials, regulatory and industry experts from 25 African countries and international health stakeholders. The meeting has spurred broad interest among African governments because the accelerated mechanism it will put in place could be used as a model for other countries to accelerate access to potentially useful therapies in emergency situations.
AVAREF was founded in 2006 by WHO to support NRAs in making informed decisions concerning authorisation of clinical trials, evaluation of product registration dossiers, and any other challenging issues related to vaccines evaluation. AVAREF provides African regulatory authorities charged with ensuring the safety of medical products and related research with expertise and opportunities for information sharing and capacity building. It also offers product developers the opportunity for joint review by regulatory authorities from multiple countries of clinical trial and marketing authorisation applications for high priority vaccines to be used in African countries. While initially focused on vaccines, AVAREF is beginning to expand to cover medicines and diagnostics as well.