WHO 预认证部门首次邀请镰状细胞病治疗药物生产商提交意向书
1st Invitation to Manufacturers of Therapeutics for Sickle Cell Disease to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit (PQT)
WHO 预认证部门发出首份镰状细胞病治疗药物意向征集，邀请生产商提交意向书参与产品评估。征集品种包括羟基脲 500 mg 胶囊，羟基脲 100 mg 和 500 mg 单刻痕可溶或分散片为优选，羟基脲 500 mg 单刻痕可溶或分散片为最低要求。
WHO 预认证部门就镰状细胞病治疗药物发出意向征集，并列明羟基脲各剂型的最低与优选要求，可供相关企业核对申报范围。
News
24 July, 2026 - 12:12 (CEST)
Announcement
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
来源：WHO 药品预认证与检查动态 · extranet.who.int