WHO publishes roadmap for introduction and roll out of a licensed Ebola vaccine
WHO has just published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epidemic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO publishes impact assessment of WHO Prequalification and regulatory supporting activities
(7 May 2019) WHO today makes available the outcomes of an independent review of WHO prequalification and regulatory supporting activities. The review aims to increase a fact-based understanding of the impact and value of WHO’s work on prequalification of medicines, vaccines and in-vitro diagnostics and supporting regulatory activities, including norms and standards setting, safety monitoring and vigilance.
The assessment highlights WHO’s impact on regulatory-focused activities and increasing access to quality-assured health products.
Hands-on learning or refreshing with WHO
From April to early August last year I was attached to the Regulatory System Strengthening team at WHO as a rotational fellow. As part of this experience, I had the opportunity to participate in a WHO inspection of a vaccine manufacturing facility in South Korea with two of WHO's experienced inspectors, Mustapha and Vimal.
My initial interest at the time was to better understand issues related to Good Manufacturing Practices (GMP) for products I work with as a quality, preclinical and clinical assessor at my agency, the Food and Drug Authority in Ghana.
Regional regulatory cooperation must for improving availability, quality of medical products
The annual meeting of South-East Asia Regulatory Network (SEARN) began in New Delhi on 24 April 2019, with WHO calling for strengthening regulatory cooperation and collaboration among countries in South-East Asia Region to further improve the availability, quality and safety of medical products.
First in vitro diagnostic prequalified through the alternative performance evaluation mechanism
For the first time, WHO has just prequalified an HIV diagnostic test through the independent performance evaluation mechanism. The mechanism was introduced to streamline assessment timelines in order to make health products more readily available and enables WHO to verify aspects of a diagnostic that are considered essential for use in resource-limited settings.
The first diagnostic prequalified through this new procedure is called m-PIMA HIV-1/2 VL and is produced by Alere Technologies GmbH.