The World Health Organization Prequalification Team - Medicines (PQT Medicines) will be attending the Shanghai SNIEC CPhI on 20-21 June 2018, 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 m is medicines and APIs needed for treating high-burden diseases and include HIV/AIDS, hepatitis C, malaria, tuberculosis, and neglected tropical diseases - and for reproductive health. A complete list of APIs and FPPs invited for prequalification can be viewed at:
Presentation
PQT Medicines will be joining other regulators to present at CPhI International Agrencies Updates and Q&A Session, hosted by China Chamber of Commerce for Import & Export of Medicines and Health Products (CCCMHPIE) on 20 June 2018.
One on One meetings with Manufacturers
PQT Medicines will also be offering the opportunity for manufacturers to meet with PQT Medicines assessment and inspection staff at the nearby Kerry Pudong Hotel on the 20 June (09:00-15:00) and 21 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: fakea@who.int, with
- cc to Dr Matthias Stahl: stahlm@who.int
For further information please contact Dr Antony Fake at: fakea@who.int
CPhI 上海 – 2018, 6月20-21
世界卫生组织药品预认证项目(WHO PQT),与中国医药保健品进出口商会(CCCMHPIE)合作， 将于2018.6.20-21参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)。
对于大多数的国际采购机构，获得世界卫生组织认证或严格监管机构 （SRA）的批准是参与药品招标的前提条件。通过世卫认证的药品（FPP）和原料药（API）公开发布在世卫网站上，证明其符合国际标准和良好的生产规范要求。通过预认证的FPP和API越来越广泛地被非洲药品监管机构所接受，从而加速药品在这些国家的注册进程。
世界卫生组织药品预认证着眼于治疗艾滋病、丙型肝炎、疟疾、被忽视的热带疾病、结核的药品，以及生殖健康药品、治疗儿童腹泻的锌剂等药品及相关的原料药。 所有邀请提交申请的原料药及制剂目录详见
讲座
6月20日， WHO药品预认证项目 工作人员将参加由中国医药保健品进出口商会举办的CPhI国际药政答疑会， 介绍预认证项目的进展并回答企业问题 (15.20pm, E2M19, SNIEC)。
与企业一对一问题解答
药品预认证项目(PQT)审评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认证的相关问题:
- 月20日(09:00-15:00)
- 月21日(09:00-17:30)
有意在此期间安排面对面讨论的企业请发邮件给 Dr Antony Fake (fakea@who.int) 预约时间，并抄送 Dr Matthias Stahl (stahlm@who.int).
如需进一步信息，请联系 Dr Antony Fake (fakea@who.int)