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The World Health Organization Prequalification Team (PQT) - Medicines in collaboration with the CCCMHPIE, will be attending the Shanghai SNIEC CPhi on 24-26 June 2015, 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 Africa and leads to faster registration.
The focus of the WHO Prequalification Team – Medicines (PQT-Medicines) is medicines and APIs needed for treating high-burden diseases such as HIV/AIDS, hepatitis C, malaria, tuberculosis, and neglected tropical diseases - and for reproductive health. Complete list of APIs and FPPs invited for prequalification can be viewed at:
http://www.who.int/prequal/info_applicants/eoi/FPPs_APIs_invited.xlsx
PQT Medicines, in collaboration with the CCCMHPIE, will attend the Shanghai SNIEC CPhi on 24‒26 June 2014, China. PQT Medicines staff will be available at the CCCMHPIE booth (E3P16) on the 24 June (09:00-17:00) and 26 June (09:00-12:00) to answer questions regaridng FPP and API prequalification procedures.
Companies who would like to arrange a face-to-face meeting for either of those days should email:
In addition, on 25 June, PQT Medicines staff will present WHO prequalification procedures and outline deficiencies commonly observed in submitted dossiers and during manufacturing site inspections to interested companies at the Exhibition Hall E3 Internal Meeting Room M22. Presentations will be given from 14:00 to 15:30, followed by discussions and further opportunities for one-on-one discussions until 17:00.
For further information please contact: Dr Antony Fake fakea@who.int
 CPHi 上海 - 2015 6月24-26
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2015.6.24-26参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
http://www.who.int/prequal/info_applicants/eoi/FPPs_APIs_invited.xlsx
WHO药品预认证项目(PQT), 与中国医药保健品进出口商会合作， 将参加2015.6.24-26在上海新国际博览中心举办的世界制药原料中国展。24日 (9.00-17.00) 及 26 日 (9.00-12.00) (E3P16) 药品预认证项目(PQT)工作人员将在中国医药保健品进出口商会展台回答有关药品及原料药认证的相关问题。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)，并抄送 Dr Matthias Stahl (stahlm@who.int).
另外，6月25日，WHO药品预认证项目(PQT)工作人员将在展览大厅E3 M22 会议室(暂定)介绍药品预认证的程序及最新发展，欢迎企业参加。报告时间为14.00-15.30，报告结束后企业将有机会与工作人员继续讨论，直到17:00。
如需进一步信息，请联系 Dr Antony Fake (fakea@who.int)
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