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PQP-overview & update January 20121
Prequalification of Medicines Overview & update
Wondiyfraw Z. Worku
WHO Prequalification of Medicines Programme
Assessment training, CopenhagenJanuary 2012
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Agenda
• PQP and its activities• PQ process flow • Some numbers and achievements• The Assessment team
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UN Prequalification Programme for Priority Essential Medicines
• A UN action plan since 2001 to expand access to priority essential medicines for– HIV, Malaria, TB, – RH, NTD, selected Influenza products, Zinc products for Acute
diarrhoea • To ensure quality, safety and efficacy of medicines
procured using international funds– Propose a list of prequalified products and APIs and
manufacturers meeting international norms and standards
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UN Prequalification Programme for Priority Essential Medicines
• Help the national medicine regulatory authorities to build up capacity in assessment, inspection and quality control meeting international norms and standards.
• Develop local possibilities of manufacturing and clinical studies by offering customized technical assistance.
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Only for essential priority medicines
• Mostly for generic products• Open only to dossiers for invited medicines (Expression
of interest)– Based on inclusion in treatment guidelines and/or WHO model
list of essential medicines
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Why PQ?
• Many of the UN and other procurement agencies lack sufficient means to ensure safety, efficacy and quality of procured medicines and other medical items.
• Many of the receiving and exporting countries do not have/did not have well established regulatory system.
• Increasing demand for generic medicines-several players- substandard products– A number of reports on sub standard Anti Tb and Malaria
products• Need for common-international standard.
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Prequalification activities• Prequalification of medicinal products and APIs
– Review of quality and safety/efficacy documentation– Inspection of manufacturing sites and CROs
• Prequalification of quality control laboratories– To identify suitable laboratories for quality testing of products
procured using international funds– Also for quality survey of products
• Technical assistance and capacity building– Help manufacturers to meet dossier and GMP requirements– To build capacity of national medicine regulatory authorities
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Similarities with NMRAs
• Like NMRAs, PQP performs- Dossier assessments- Inspections- Quality control testing (mostly through post approval sampling)- Also post approval pharmacovigilance activities (through sister units within EMP/QSM)
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Differences from NMRAs
• Priority therapeutic areas• Assessments and inspections by international experts• Marketing authorization is not issued.• Prequalification of APIs• Prequalification of quality control laboratories• Provides technical assistance to applicants• No fees
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Process flowApplication for prequalificationDossier, Samples & SMF
ScreeningApplicant
GMP
Review of GMP Certification,
Inspection reports, Site Master Files (SMF).
Informationrequested
Application accepted for assessment
Assessment
Accepted Accepted
Applicant
ManufacturerInspection
Corrective and preventative actions
Final decision on prequalification
Listing on WHO website
VariationsComplaints
Random samplingRequalification
Informationrequested
Informationrequested
Expression of interest (EOI)
WHOPIR
WHOPAR
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Major achievements in 2011• The revised CTD based main guideline for multi source
generic products is being implemented• Another product from Sub-Saharan Africa manufacturer
prequalified. • 35 FPPs including 7 second line anti-TB products were
prequalified– First two generic RH products were prequalified– First ICH generic product was prequalified– First Active Pharmaceutical Ingredients were prequalified
• Two new APIs included in the biowaiver list• Revised variation guide soon ready for public comment
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List of products included in WHO prequalified products list
Prequalified products
75%
13%
6% 4% 2%HIVTBMalariaRHInfleunza
75%
13%6% 4%2% HIV
TBMalariaRHInfleunza
• Prequalified generics and innovators as of December 31st 2011: 274 products (assessed and inspected by PQ)
• Total listed as of December 31st 2011 (including those listed based on USFDA/EMA/HCnda approvals): 366 products
0
5
10
15
20
25
30
35
40
45
50
2007 2008 2009 2010
HIV TB Malaria RH Influenza USFDA
0
10
20
30
40
50USFDAInfluenzaRHMalariaTBHIV
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Inspections
0
5
10
15
20
25
30
35
40
2005 2006 2007 2008 2009 2010 2011
FPPAPICROQCL
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Prequalified / interested laboratoriesDecember 2011 Prequalified QCLs:
South Africa, RIIP+CENQAM (2005) Algeria, LNCPP (2005) South Africa, Adcock Ingram (2007) Morocco, LNCM (2008) Kenya, NQCL (2008) India, Vimta Labs (2008) France, CHMP (2008) Vietnam, NIDQC (2008) Kenya, MEDS (2009) Singapore, HSA (2009) Singapore, TÜV (2009) Canada, K.A.B.S. Laboratories
(2010) Ukraine, CLQCM (2010) Ukraine, LPA (2010) Peru, CNCC (2010) Uruguay, CCCM (2010) Bolivia CONCAMYT (2010) TFDA, Tanzania (2011) SGS, India (2011) SGS, Belgium (2011) Proxy, Netherlands (2011) INFARMED, Portugal (2011) FUNED, Brazil (2011)
14
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Technical assistance to applicants
• More than 80 technical assistance missions have been organized and delivered
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Trainings
• More than 95 trainings have been delivered
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The assessment process in more detail
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The assessment teamHead of
Assessments
Quality assessors (API and FPP) BE assessors
Clinical assessors(Clinical data
and WHOPAR)
- More than 50 temporary advisors )pool of external assessors( - Six full time in-house and one rotational assessor.
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The Assessment process
• Six sessions per annum (every other month) here in CPH.
• More than 30 assessors per session• At least two assessors for every dossier assessment• A final QA process when the dossier is close to PQ
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Assessors tools
• WHO and other guidelines• Pharmacopoeias• Internal guides (alerts)• Previous assessment reports• Discussion with colleague assessors
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The ideal place to learn
• Extensive discussion with experienced assessors coming from all corners of the world– A mix of ICH and non-ICH assessors
• Access to full dossier as compiled for stringent regulatory authorities
• Access to full previous assessment and inspection reports
• Adequate time for assessment• A chance to join the PQP team for a three months
rotational position in Geneva
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Assessors working
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• Notice of concerns & related info
• Prequalification lists
• Procedures & Guidelines
• Prequalification of APIs
• Inspection info • Trainings and
meetings• Public
assessment and inspection reports
www.who.int/prequal
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Thank you