WHO Prequalification

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• WHO Prequalification Medicines Assessments
• Andrew Chemwolo, Technical Officer
• Prequalification Team Medicines
  Assessment

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Medicines Assessment

• Group within PQT involved in assessment of
  applications for medicines prequalification.
• Only product dossiers for medicines included in
  the Invitation for Expression of Interest (EOI)
  are considered for prequalification

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Invitation for Expression of Interest (EOI)

• Contains a list of medicines invited for
  prequalification
• Priority public health medicines
• List prepared by WHO clinical experts/departments
  (HIV, TB, Malaria, RH, Influenza, Diarrhoea
  (Zinc), NTD)
• Based on inclusion in WHO treatment guidelines
  and/or WHO model list of essential medicines
• EOIs are published on WHO PQ web site
• List revised as needed to capture new
  developments

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Therapeutic areas

• Therapeutic areas invited are
• HIV/AIDS, including hepatitis B C
• Malaria
• Tuberculosis
• Reproductive Health (RH)
• Influenza
• Acute diarrhoea in children (zinc)
• Neglected Tropical Diseases (NTDs)

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Current Expressions of Interest

• Currently 8 EOIs are published
• HIV/AIDS, including hepatitis B C 12th
• Influenza 2nd
• Malaria 11th
• Neglected Tropical Diseases (NTD) 3rd
• Reproductive Health 6th
• Tuberculosis 12th
• Diarrhoea (Zinc) 1st
• Active Pharmaceutical Ingredients 7th

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Prequalification process
Expression of Interest
Product dossier Site Master File
Inspections
Assessment
Additional information and data
Corrective actions
Acceptable
Compliance
Prequalification
Maintenance and monitoring
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Prequalification of medicines

• Common prequalification process for all
  therapeutic areas.
• Stages
• Receipt of application
• Screening and acceptance for assessment
• Assessment of Quality and Efficacy/Safety data
• Inspection of manufacturing sites (FPP, API) and
  CROs
• Prequalification/listing
• Maintenance/Monitoring of the products after
  prequalification
• Variations, Requalification, Inspections, Random
  QC sampling, Investigation of complaints etc.

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Dossier assessments

• Quality and Efficacy/Safety parts of dossier
  assessed in parallel
• Several rounds of communication with applicants
• QA step at the end of the assessment process
• Close coordination with inspectors
• Product listed (prequalified) once all
  requirements are met and letter of
  prequalification issued to applicant.

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Dossier assessments

• WHO, ICH, specific PQ guidelines and recognized
  pharmacopoeias are applied
• All the relevant guidelines and forms published
  on WHO PQ web site (http//www.who.int/prequal/)
• Abbreviated process for prequalifying medicines
  approved by a stringent regulatory authority
  (SRA) to avoid duplication

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Paths for inclusion of a product in the list of
prequalified products

• Prequalification of multisource generic products
• Full review of dossier and inspection of sites by
  WHO PQ
• Prequalification of innovators
• Approval based on marketing authorization issued
  by an SRA
• Prequalification of generic products approved by
  an SRA
• Approval based on SRA marketing authorization
• Recognition of temporary approvals / scientific
  opinions
• USFDA PEPFAR approval/tentative approval
• EMA article 58
• Health Canada Access programme

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Requalification

• Review after five years from the date of
  prequalification of the product, or when
  requested to do so by WHO PQ (whichever date is
  earlier)
• Procedure applicable to products fully assessed
  and prequalified by WHO PQ.
• Purpose of requalification
• Ensure that the listed products conform to
  current norms and standards.
• Follow up on commitments made at time of
  prequalification

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API Prequalification

• Started as a pilot project in October 2010.
• It is a scheme for manufacturers of APIs that are
  used in invited medicinal products (current 7th
  EOI).
• It seeks to verify and identify APIs that are of
  good quality and manufactured in compliance with
  GMP.
• Involves assessment of the APIMF and inspection
  of manufacturing sites.

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API prequalification

• List of prequalified APIs published on the WHO PQ
  web site
• Applicants with prequalified APIs are issued with
  a WHO Confirmation of API Prequalification
  document.

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WHO Public Assessment Report (WHOPAR)

• Aims to make assessment outcomes publicly
  available
• Composed of 8 parts, including those for SmPC,
  PIL Labelling
• Report summarizes assessment of the product data
  and information submitted in the product dossier
  (excluding confidential/proprietary information).
• Reports published on the WHO PQ web site
• Updated regularly

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Web site http//www.who.int/prequal/
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Products under assessment
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Further information

• Further information http//www.who.int/prequal/
• Email prequalassessment_at_who.int or
  stahlm_at_who.int (Dr. Matthias Stahl)

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• Thank you!