The World Health Organization Prequalification Teams - Medicines Assessment and Inspections - will be attending the Shanghai SNIEC CPhi on 16-18 June 2026, in Shanghai, China.
For most international procurement agencies, WHO prequalification or stringent regulatory approval is a prerequisite when applying for medicine tender contracts. WHO-prequalified finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) are publicly listed and recognized as meeting international quality and good manufacturing practice requirements. Increasingly, the prequalification status of an FPP and API is accepted by national regulatory authorities in Low and Middle Income Countries (LMICs) and leads to faster registration.
- The focus of PQT Medicines is on medicines and APIs that are needed for treating high-burden diseases. A complete list of APIs and FPPs invited for prequalification can be viewed at: https://extranet.who.int/prequal/medicines/fpps-apis-eligible-prequalification-eois
Presentation
PQT Medicines and Inspection experts will be joining other regulators to present at CPhI International Agencies Updates and Q&A Session, hosted by China Chamber of Commerce for Import & Export of Medicines and Health Products (CCCMHPIE) in the morning of the 17 June 2026.
One on One meetings with Manufacturers
PQT will also be offering the opportunity for manufacturers to meet with PQT Medicines and Inspection staff at the nearby Kerry Pudong Hotel on the 16 June (09:00-17:30), 17 June (14.30-17:30) and 18 June (09:00-17:30) to answer questions regarding FPP and API prequalification procedures.
Companies who would like to arrange a face-to-face meeting for either of those days should request a meeting form via email to:
• Dr Antony Fake at fakea@who.int.
世卫药品预认证团队将参加上海 CPHi 展会–2026 年6月16-18 日
世界卫生组织药品预认证团队(WHO PQT/MED), 将于2026 年6月16-18 日参加在上海新国际博览中心举办的世界制药原料中国展(Shanghai SNIEC CPhi)。
对于大多数国际采购机构而言，在申请药品招标合同时，获得世界卫生组织（WHO）预认证或严格监管机构（SRA）的批准是一个前提条件。经 WHO 预认证的药品（FPP）和原料药（API）会被公开发布在世卫网站上，并被认可为符合国际质量标准和良好生产规范（GMP）要求。通过预认证的FPP和API正越来越广泛地被低收入和中等收入国家（LMICs）的药品监管机构所接受，从而加快其在这些国家的注册审批进程。
世界卫生组织药品预认证主要针对用于高负担疾病治疗的药品及其相关的原料药。受邀提交预认证申请的原料药及制剂完整清单可在以下网址查看 https://extranet.who.int/prequal/medicines/fpps-apis-eligible-prequalification-eois
报告会
WHO药品预认证团队及GMP检查领域的专家将与其他监管机构代表一同参加由中国医药保健品进出口商会（CCCMHPIE）主办的 CPhI 国际机构最新动态及问答交流会，并将在 2026 年 6 月 17 日上午进行报告分享。
与企业一对一问题解答
药品预认证项目(PQT)审评员和检查员将于以下时间在上海浦东嘉里大酒店 (上 海 浦 东 新 区 花 木 路 1388 号)回答企业关于原料药和制剂预认证的相关问题:
• 6月16日 (09:00-17:30)
• 6月17日 (14:30-17:30)
• 6月18日 (09:00-17:30)
有意在上述任一日期安排面对面会议的公司，请通过电子邮件索取会议申请表：
• 请发邮件给 Dr Antony Fake at fakea@who.int.