WHO 发布第43次原料药预认证意向书邀请，新增氢化可的松（琥珀酸钠）、放线菌素D、长春新碱和阿糖胞苷
43rd Invitation to manufacturers of Active Pharmaceutical Ingredients (API) to submit an Expression of Interest (EOI) for API evaluation to the WHO Prequalification Unit (PQT)
WHO 药品预认证单位发布第43次原料药意向书邀请，向原料药生产商征集预认证评估申请，本次邀请新增氢化可的松（琥珀酸钠）、放线菌素D、长春新碱和阿糖胞苷4种原料药。
WHO 第43次原料药预认证邀请新增4种原料药，可帮助原料药企业核对本次受理的品种范围。
News
18 August, 2026 - 00:12 (CEST)
Announcement
A 43rd invitation to manufacturers of Active Pharmaceutical Ingredients (API) to submit an Expression of Interest (EOI) for API evaluation to the WHO Prequalification of Medicines Programme has been published.
This 43rd invitation has been expanded to include:
• Hydrocortisone (sodium succinate)
• Dactinomycin
• Vincristine
• Cytarabine
API prequalification is intended to support national and global efforts to increase access to and the affordability of care and treatment of priority diseases, by identifying suppliers of high quality API for prospective FPP manufacturers and National Medicine Regulatory Agencies.
Further information on the API Prequalification can be found at this link: http://www.who.int/prequal/info_applicants/API_info_applicants.htm.
Manufacturers of APIs, particularly, those already involved in the FPP prequalification programme through the APIMF procedure are encouraged to consider the benefits that recognition as a prequalified API might offer to them.
来源：WHO 药品预认证与检查动态 · extranet.who.int