The World Health Organization Prequalification Team: medicines (PQTm) will be attending the Shanghai SNIEC CPhi on 20-22 June 2017, 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 PQTm 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. A complete list of APIs and FPPs invited for prequalification can be viewed here
Presentation
PQT Medicines 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) on 21 June 2017.
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 AM - 17:00); 21 June (09:00 AM - 12:00 PM) and 22 June (09:00 AM - 17:00) 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 email:
- Dr Antony Fake at fakea@who.int
- with cc to Dr Matthias Stahl at stahlm@who.int
For further information please contact: Dr Antony Fake