WHO Prequalification Programme: example of available regulatory expertise for some medicinal products

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WHO Prequalification Programme example of
available regulatory expertise for some medicinal
products

• Mi

Milan Smid Quality Assurance and Safety
Medicines Prequalification Programme
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UN Prequalification Programme for Priority
Essential Medicines

• Action plan of UN from 2001 for expanding access
  of priority medicines to patients with
• HIV/AIDS
• Malaria
• Tuberculosis
• Reproductive health
• Potentially other categories of products
• Antiviral medicines efficacious for avian flue
• Paediatric formulations

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Elements of Prequalification Programme

• Objective
• To ensure quality, efficacy and safety of
  medicines procured using international funds
  (e.g. GFTAM, UNITAID)
• Components
• Evaluation of Quality, Safety and Efficacy of
  prioritised Essential medicines, inspections of
  manufacturers and monitoring of the products
  after their prequalification.
• Prequalification of quality control laboratories.
  
• Building capacity of regulators, manufacturers
  and quality control laboratories.

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How prequalification is organized?

• WHO PQT working in co-operation with partners
• UNICEF
• UN Population Fund (UNFPA)
• UNAIDS
• World Bank
• Anti-malarial and anti-TB products Roll Back
  Malaria and Stop TB (Global Drug Facility)
  HIV/AIDS Department

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How prequalification is organized?

• WHO manages and organizes the programme on behalf
  of the United Nations
• provides technical and scientific support to
  assessment, inspections (GMP, GCP, GLP) and
  quality control (GPCL)
• involvement of qualified assessors and inspectors
  mostly from NRAs of ICH and associated countries
  and PIC/S inspectorates
• guarantees that international norms and standards
  are applied all through the process
• supports capacity of NRA in developing countries
  to evaluate, inspect and control the quality of
  medicines
• involvement of qualified assessors and inspectors
  from NRAs in developing countries
• by involvement of manufacturers from development
  countries into the project supports their
  capacity to produce according to international
  norms and standards

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Assessment of products

• Innovator products
• If approved by stringent authorities like US FDA
  and EMEA
• Based on availability of assessment reports, WHO
  Certificate of Pharmaceutical Product (CPP),
  batch certificate and continuous update on
  product changes after prequalification
• Confidence in scientific expertise of
  well-established RAs,

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Assessment of products

• Multisource products
• Assessment of
• Quality information on starting materials and
  finished product, (API details, specifications,
  stability data, formulation, manufacturing
  method, packaging, labelling etc.)
• Efficacy and safety Report of bio-equivalence or
  clinical study demonstrating interchangeability
  with reference product
• Inspection of manufacturers and CROs
• Laboratory analysis in case of need
• Monitoring after prequalification

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Essential steps of PQ procedure

• Expression of interest (EOI) is published
• Interested parties submit dossiers
• Dossiers receive initial screening
• Full dossiers are assessed
• Inspections are conducted at manufacturing sites
  and at CROs
• Samples are tested, if needed
• If outcome is positive, pharmaceutical product is
  listed on the website, including product
  information (SPC, PIL), assessment report
  (WHOPAR) and inspection report (WHOPIR)

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Essential steps of monitoring of PQ product

• Variations to the dossier of prequalified product
• Sampling and Testing
• Reinspections
• Reevaluation
• De-listing or suspension (if and when appropriate)

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Outcomes of PQ procedure

• Information in public domain (homepage)
• Lists of PQ medicinal products
• WHOPAR (SPC, PIL, labelling)
• WHOPIR (both FPP and API)
• Information on progress of assessment procedure
  and inspections
• Supportive documents WHO guidelines, description
  of PQ procedure
• Restricted information (available based on
  consent of applicant with information sharing)
• Complete WHOAR
• Complete WHOIR
• Deficiency letters and prequalification letter

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Prequalified medicinal products according to
therapeutic categories Status 30.8.07, in total
189 products
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Prequalified medicinal products (source of
expertise indicated for listed products)
Status 30.8.07, in total 189 products
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Number of prequalified products manufactured in
individual countries (N206)
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Contribution of PQ to capacity building

• Organization of trainings
• general and problem specific (HIV/AIDS, TB and
  antimalarial products, pediatric dosage forms,
  BE, BE/BCS)
• Trainings of NRA staff and manufacturers
  frequently combined
• Involvement of assessors from NRAs into PQ
  assessment
• Involvement of inspectors from NRAs into PQ
  inspections
• 3 months rotations of experts from NRAs in WHO HQ