WHO 首次邀请儿童肿瘤治疗药品生产商提交预认证意向书（EOI）
1st Invitation to manufacturers of medicinal products for treatment of childhood cancer, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
WHO 于2026年8月13日发布首次邀请，邀请儿童肿瘤治疗药品生产商提交意向书（EOI），由预认证部门评估产品。邀请涵盖两类产品，一是需要开发儿童适用剂型的优先儿科肿瘤药，二是用于应对供应与可及性缺口的部分必需抗癌药。2024年1月的儿科药物优化（PADO）工作确定了环磷酰胺、依托泊苷、巯嘌呤、甲氨蝶呤、丙卡巴肼和替莫唑胺六个优先药物，WHO 已为其制定目标产品概况（TPP）。
WHO 首次邀请儿童肿瘤治疗药品生产商提交预认证意向，材料说明了两类受邀产品的划分依据与六个优先药物。
News
13 August, 2026 - 00:12 (CEST)
Announcement
The first Invitation to Manufacturers of Medicinal Products for the Treatment of Childhood Cancer to submit applications for evaluation under the WHO Prequalification Programme has been issued following a request from WHO’s Department of Noncommunicable Diseases and Mental Health (NMH), including its hosted Global Platform for Access to Childhood Cancer Medicines, in collaboration with the Global Accelerator for Paediatric Formulations (GAP-f) Secretariat hosted by the Science for Health (SFH) Department.
In January 2024, WHO convened a Paediatric Drug Optimization (PADO) exercise for cancer medicines to identify priority products with approved paediatric indications but lacking suitable child-friendly formulations. This process identified six priority medicines for formulation development: cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine, and temozolomide. WHO subsequently developed target product profiles (TPPs) for these medicines, which are now being invited for prequalification to stimulate the development and availability of age-appropriate formulations for children.
In parallel, NMH recommended the inclusion of a limited number of additional medicines that are already recognized as essential medicines and for which significant access gaps in childhood cancer care have been documented. This list of products was developed through a structured prioritization process led by the Global Platform for Access to Childhood Cancer Medicines and undertaken in consultation with key partners and stakeholders.
As a result, the invitation encompasses two complementary categories of products: first, priority paediatric oncology medicines for which the development of suitable child-friendly formulations is needed; and second, selected essential cancer medicines intended to address critical supply and access gaps and support continuity of care for children with cancer.
Through this invitation, WHO aims to encourage the development, evaluation, and procurement of quality-assured cancer medicines that meet the treatment needs of children worldwide and contribute to improving equitable access to essential childhood cancer therapies.
Manufacturers interested in submitting applications for any of the invited products are encouraged to contact WHO Prequalification of Medicines (PQT/MED) for further information, regulatory advice, or clarification regarding application requirements and pathways.
来源：WHO 药品预认证与检查动态 · extranet.who.int