Transcript Technical Briefing Seminar on Quality Assurance and Safety of Medicines Assessment of Medicines Dr M Stahl Head of Assessments Prequalification of Medicines Programme Quality Assurance and.

Technical Briefing Seminar on Quality
Assurance and Safety of Medicines
Assessment of Medicines
Dr M Stahl
Head of Assessments
Prequalification of Medicines Programme
Quality Assurance and Safety: Medicines (QSM)
Department of Essential Medicines and Pharmaceutical Policies (EMP)
Health Systems and Services (HSS)
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QSM TBS 20 November 2009
Invitation for Expression of Interest (EOI)
 Decided by WHO disease oriented programmes based on
perceived need
 Requirements for inclusion;
Included on the WHO Model List of Essential Medicines
or
An application for inclusion has been submitted to the EML EC and
it can be shown to be likely to meet the criteria for inclusion (public
health need, comparative effectiveness, safety and costeffectiveness)
or included in the current WHO treatment guideline
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Main steps
Application
PQIF, BTIF, Dossier
Screening
Acceptance for Assessment
Pre-Assessment
Assessment
Report
Prequalification LoP
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Requalification
Additional Data
Standards
 WHO standards as defined in WHO guidelines and
International Pharmacopoeia
– If these do not exist, ICH guidelines are applied
 Same principles as for national regulatory approvals by
stringent authorities
– Data on quality and efficacy/safety or interchangeability
– Compliance with GMP (finished product, APIs), GCP/GLP
(bioequivalence studies)
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Assessment sessions
Assessment of the product dossier i.e. quality specifications (API
and FPP), pharmaceutical development, stability,
bioequivalence…
Copenhagen assessment week
- 20+ assessors - 5 days - once every two months
- The assessment report is reviewed by a second assessor - both
assessors sign the final report
- Additional data requested if necessary; first by e-mail, then
surface mail
 Handling of variations to prequalified product dossiers
- Done in-house (Geneva) on a continuous basis
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Product dossiers accepted for assessment
2005
2006
2007
2008
HIV
67
42
25
42
24
TB
17
9
17
12
10
Malaria
3
5
7
9
3
Repr Health
-
-
10
4
4
Influenza
-
-
-
1
7
Diarrhoea
-
-
-
-
1
59
68
49
87
92
57
Total Dossiers Accepted 87
Total Dossiers Submitted
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56
2009 (30 Oct 2009)
Currently under assessment
As of 30 Oct 2009:
 64 products for treatment of HIV/AIDS and related diseases
 2 products for treatment of influenza (EOI 2008)
 42 products for treatment of tuberculosis
 17 products for treatment of malaria
 13 reproductive health products (EOI 2006)
 1 zinc product for treatment of diarrhoea (EOI 2008)
 Total 139
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Dossier status on the web
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Times
Time (median) from receipt of a dossier to start of assessment:
47 days (2007)
33 days (2008)
Time (mean) to prequalification:
26 months (2007)
23 months (2008; median 18.7 months, 19.1 months for generics
only)
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Characteristics of prequalified product
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Products included in the WHO list of prequalified medicines (by therapeutic area)
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Products included in the WHO list of prequalified medicines (cumulative numbers)
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Products included in the WHO list of prequalified medicines by therapeutic area
(cumulative numbers)
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WHOPARs and WHOPIRs
 These are published in response to the WHA Resolution WHA57.14 of 22 May 2004, which
requested WHO:
"3. (4) to ensure that the prequalification review process and the results of inspection and
assessment reports of the listed products, aside from proprietary and confidential
information, are made publicly available;"
 A WHO Public Assessment Report (WHOPAR) is a summary of the quality and efficacy/safety
assessments for a product at the time of prequalification and includes the Summary of Product
Characteristics (SPC) and PIL
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Variations 2008
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Variations 2009 (as of 30 Oct)
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Requalification of prequalified dossier (generics)
 Guidance adopted by EC in Oct 2009
 Every 5 years (at least), earlier if omissions, fraud or batches not
compliant with spec's
 Questions: Product acceptable according to current norms and
standards? Quality of the FPP and its manufacturing processes
consistent?
 Documents; Cover letter, summary of key product information (LoP
– now, then), all variations, PQIF (according to current guidelines),
prequalified and current API and FPP specifications and test
methods, Product Quality Review.
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