The 1st Invitation for the submission of medicinal products for the treatment of Sickle Cell Disease for product evaluation by prequalification has been issued, based on a request from WHO’s Department of Sexual, Reproductive, Maternal, Child and Adolescent Health and Ageing (LHR), in conjunction with the GAP Secretariat hosted by the Science for Health Department
WHO is in the process of publishing clinical guidelines on the management of SCD in children and adolescents, with a strong recommendation for the use of hydroxyurea in children and adolescents from 9 months to 19 years of age with sickle cell anaemia (SCA), regardless of clinical severity (strong recommendation, low certainty of evidence). Discussions during guideline development underscored the urgent need to ensure the availability of appropriate child-friendly formulations to enable safe dosing, adherence, and equitable access.
The current invitation for expression of interest (EOI) invites
Hydroxyurea 500 mg capsules
Hydroxyurea 100 mg and 500 mg single-scored soluble or dispersible tablets preferred
Hydroxyurea 500 mg single-scored soluble or dispersible tablets as a minimum requirement
Please see the EOI for further information