un prequalification programme
DESCRIPTION
UN Prequalification Programme. Milan Smid WHO Prequalification of Medicines Programme. UN Prequalification Programme for Priority Essential Medicines. Action plan of UN from 2001 for expanding access to selected priority medicines Objective: - PowerPoint PPT PresentationTRANSCRIPT
UN Prequalification Programme UN Prequalification Programme
Milan SmidWHO Prequalification of Medicines Programme
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20112
UN Prequalification Programme for Priority Essential Medicines
Action plan of UN from 2001 for expanding access to selected priority medicines
Objective:
• To ensure quality, efficacy and safety of medicines procured using international funds (e.g. GFTAM, UNITAID) to serve patients in developing countries
Components:
• Evaluation of Quality, Safety and Efficacy of prioritised Essential medicines (FPPs and APIs), 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.
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20113
Potential benefits for manufacturers
• Participation in tender procedures organized by international procurers and financial profit
• Recognition as being WHO listed company
• Facilitated registration in some recipient countries
• Reduction of inspections from recipient countries
• Possibility to be assisted by expert consultants (GMP, dossier)
• Learning process improving company's chance to succeed with submissions to SRAs
• Recognition of prequalified APIs
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20114
Reported Procurement information http://www.theglobalfund.org/en/procurement/pqr/
• Products/Manufacturers distribution
ARV Anti-malarial
anti-TB
Branded: 34%
Branded: 70%
Branded: 22%
Generic: 66%
Generic: 30%
Generic:78%
Over 1, 400 million* US of transactions reported in the PQR system
Sophie Logez, GFATM, March 2011
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20115
Quality Criteria
For all productsAuthorization for use in the recipient countries
For ARVs, anti-TB and anti-malarial products
WHO Prequalified or authorized by a Stringent Regulatory Authorities;orRecommended for use by an Expert Review Panel: Only If <2 WHO PQed or SRA authorized products available
GFATM Quality Assurance Policy for Pharmaceuticals (since 2009)
Clinical Criteria
Medicines listed in WHO or national or institutional Standard Treatment Guidelines
Monitoring Quality
• Monitoring quality of products all along the supply chain
• Systematic random quality control testing
• Recipients report testing results to Global Fund
+ +
Sophie Logez, GFATM, March 2011
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20116
Availability and capacity
Sophie Logez, GFATM, March 2011
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20117
HIV / AIDS51 recipient countries
Malaria29 recipient countries
Tuberculosis76 recipient countries
> US$600 mil > US$300 mil- Cross cutting programs: US$109 m for PQ of drugs & diagnostics and transversal programs
> US$200 mil
COUNTRIES RECEIVING COMMODITIES…US$1.1Billion UNITAID funds
Lorenzo Witherspoon, UNITAID, March 2011
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20118
Categories of medicines invited• Primary categories of medicines:
– HIV/AIDS– Malaria– Tuberculosis
• Later added:– Reproductive health– Influenza– Acute diarrhoea
• Potentially other categories of products, if there is the need (neglected diseases)
• Prequalification also applicable for APIs
• Published in invitations for Expression of Interest (EOI) on Prequalification website
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 20119
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 developing countries into the project supports their capacity to produce according to international norms and standards
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201110
Essential steps of PQ evaluation procedure
• Need is specified and agreed by WHO treatment programmes
• Invitation for 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)
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201111
Essential steps of monitoring of PQ product
• Variations to the dossier of prequalified product
• Sampling and Testing
• Reinspections
• Requalification
• Management of complaints
• De-listing or suspension (if and when appropriate)
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201112
I
Expression of Interest
Compliance
Additional informationand data
Corrective actions
Compliance
Assessment Inspections
Steps in WHO prequalification
Prequalification
Maintenance and monitoring
Product dossierSMF
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201113
Invitation for expression of Interest
Dossier and SMF submitted for assessment
Valid for innovators and generics
Two prequalification routes
Medicine assessedby SRA
Medicine notassessed by SRA
WHO assessmentand inspections
organized
Compliance Prequalification
SRA registration )assessment and
compliance check(
Acceptance
Simplified review
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201114
Evaluation procedure Assessment of product dossiers
(Quality specifications, pharmaceutical development, production, control, stability, bioequivalence etc).
Teams of professionals from national Drug Regulatory Authorities (DRA): Including Brazil, China, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Indonesia, Malaysia, Philippines, Spain, South-Africa, Sweden, Switzerland, Tanzania, Uganda, UK, Zimbabwe ...
Copenhagen assessment week
• 8 to 20 assessors together during one week at least every two months at UNICEF in Denmark
• Every dossier is assessed by at least four assessors. • An assessment report is issued - signed by assessors• Letter summarizing the findings and asking for clarification and
additional data if necessary is sent first by e-mail to the applicant followed by surface mail
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201115
Inspections
• Team of inspectors for each inspection
• WHO PQ inspector plus PIC/S member country plus local country inspector (observer)
• Some cases – capacity building (recipient country)
• Preparation includes SMF, product information, inspection reports, complaints etc
• Inspections are product oriented
• APIs and Bioequivalence studies inspected based on risk assessment
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201116
Standards
• WHO standards as defined in WHO guidelines and International Pharmacopoeia are applied in prequalification process
• If these not exist, ICH guidelines are applied
• In case of need, guidelines of stringent regulatory authorities, which are involved in ICH process
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201117
Outcomes of PQ procedure
Information in public domain: http://www.who.int/prequal/
• Lists of PQ medicinal products
• WHOPAR (SPC, PIL, labelling)
• WHOPIR (both FPP and API)
• Notices of Concern and Suspensions
• Information on progress of assessment procedure and inspections
• Supportive documents: WHO guidelines, description of PQ procedure, training materials
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201118
www.who.int/prequal/
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201119
Products already prequalified (XII/2010)
• Prequalified generics and innovators as of December 31st 2010: 252 products (assessed and inspected by PQ)
• Total listed as of December 31st 2010 (including those listed based on USFDA/EMA/HCnda approvals): 350 products
191
2917 8 7
HIV TB Malaria RH Influenza
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201120
Prequalified priority essential medicines Prequalified priority essential medicines (September 2010)
0
50
100
150
200
250
HIV/AIDS Tuberculosis Malaria
FDC
Mono-component
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201121
1 1 2 2 2 2 5 5 6 7 915
26 26
141
0
20
40
60
80
100
120
140
160
Prequalified medicines according to the country of applicant
China
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201122
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, GMP)
– 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 – PQT
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201123
165
198
10357
263
301
568
396
282
4944
805
203
130
73
0
200
400
600
800
1000
1200
1400
2007 2008 2009 2010
Participants in trainings organized or co-organized/supported by PQP
Others
QCL staff
Regulators
Manufacturers
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201124
Countries hosting workshops organized or supported by Prequalification Programme in 2006-2010
0
2
4
6
8
10
12
14
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201125
Technical Assistance
• Provision of expert consultants to– Manufacturers – Quality control laboratories– Regulators
• Assistance focuses on – GMP, GCP or GLP compliance– Dossier development
• Assistance is separated from the assessment / inspections and may be followed by specific trainings
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201126
Conditions for provision of technical assistance
Manufacturers:• Participation in the prequalification programme,• Found to be capable and willing to improve• Location in a developing country
Products:• Inclusion in the list of expression of interest• High value for Public Health purpose • Poor representation on the Prequalification list.
WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201127
TAs organized in individual countries (2006-2010)
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WHO Prequalification Programme, Beijing, P.R. China, DIA, May, 201128
Thank you for the attention