Transcript The WHO Prequalification of Medicines Programme Capacity building agenda Dr Milan Smid Capacity building - objectives • Good quality submissions for PQ supported by compliance.

The WHO Prequalification of Medicines
Programme
Capacity building agenda
Dr Milan Smid
Capacity building - objectives
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Good quality submissions for PQ supported by compliance with "good
practices"
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Fast regulatory approvals of PQ medicines in recipient countries
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platform for improvement of drug development, manufacturing,
documentation and quality control
technical education of regulators as a platform for strengthening expertise,
regulatory efficiency and networking
Reliable quality monitoring
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technical education of staff of QCLs to strengthen expertise, effectiveness of
quality monitoring and networking
PQP standards and PQP example support strengthening of regulatory
systems and capacity of manufacturers in general
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Capacity building – team work
1) Trainings of
different set-up
2) Technical
assistance &
advice
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3) Provision of information,
standards and regulatory
expertise
1) Trainings
• Seminars and workshops
– General: PQ procedures and WHO requirements
– Problem oriented, e.g.:
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HIV/AIDS, TB, antimalarial or RH products
Pharmaceutical development/paediatric dosage forms, BE/BCS
Manufacture of sterile medicines
Quality of APIs
Trainings of NRA staff and manufacturers frequently combined
Collaboration with third parties frequent involved
Support is given to trainings organized by others
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Focus on "training of trainers"
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WHO training materials used, when available (GMP, GPCL)
• Training by doing
– Inspectors, assessors, rotations within PQP
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3
12
21
8
9
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Prequalification advocacy
Prequalification requirements
Good manufacturing practice
Quality control
Bioequivalence/BCS and GCP
Assessment of medicines
Pharmaceutical development and quality
API quality
PQ general/Regulatory
PQP trainings
Participants in trainings organized or
co-organized/supported by PQP
Trainings organized or supported by PQP
18
800
3
16
5
14
4
12
PQP supported
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8
15
11
PQP organized
500
400
300
12
9
84
Others
184
QCL staff
282
57
103
301
Regulators
198
Manufacturers
396
200
4
2
48
68
5
600
4
6
44
49
700
359
263
4
100
0
165
0
2006
2007
2008
2009
2010 Oct
2007
2008
2009
2010 Aug
Countries represented in trainings
60
56
59
52
50
43
40
30
20
10
0
2007
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2008
2009
2010 Aug
2) Technical Assistance
• Key objective: Facilitate prequalification of
priority medicines
• Provision of consultants to advice on
– GMP or GCP compliance
– Data development and compilation of dossier
• Assistance is separated from the assessment
/ inspections
• Assistance may be followed by specific
trainings
• Assistance is provided free of charge
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Technical assistances
2006-2010 (I-VIII)
14
12
4
3
10
1
2
8
3
REG
25
GPCL
2
GCP
6
3
20
10
GMP
8
4
7
7
1
REG
15
2
GCP
2
0
GPLC
10
2006
2007
2008
2009
GMP
2010
5
0
AFRO
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AMRO
EMRO
EURO
SEARO
WPRO
3) Provision of information and
regulatory expertise
• Information related to individual PQ products or manufacturers /
CROs
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Product list and pending procedures
Public assessment reports (WHOPAR, SPC, PIL)
Public inspection reports (WHOPIR – APIs and FPPs)
Notice of concern / suspension
Development of guidelines and standards
• Published training materials / CDs
• Technical Briefing Seminars in Geneva
• http://www.who.int/prequal
– PQ medicines and laboratories, guidelines, training materials
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Support to projects relevant for PQP
• National authorities indicate the interest to collaborate with
WHO and the needs - WHO proposes solutions and supports
the actions
• WHO focuses on actions having impact on public health
aiming to achieve self-sustainability of health and safety
management operations in the country
• WHO supports projects in countries by co-ordinated effort of
Country Offices, Regional Offices and HQ
• Key expert resources are frequently external, from the pool
of international experts in WHO Member States
• Successful projects create benchmark and increase chance
for further support and other projects
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Contact for communication
Milan Smid, M.D., Ph.D.
Quality Assurance and Safety: Medicines (QSM)
Essential Medicines and Policy (EMP)
[email protected]
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