pqp-overview & update january 2012 1 prequalification of medicines overview & update...

PQP-overview & update January 20121

Prequalification of Medicines Overview & update

Wondiyfraw Z. Worku

WHO Prequalification of Medicines Programme

Assessment training, Copenhagen

January 2012


Agenda

• PQP and its activities• PQ process flow • Some numbers and achievements• The Assessment team


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


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.


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


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.


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


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)


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


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



Expression of interest (EOI)

WHOPIR

WHOPAR


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


List of products included in WHO prequalified products list

Prequalified products

75%

13%

6% 4% 2%

HIVTBMalariaRHInfleunza

75%

13%6% 4%2% HIV

TB

Malaria

RH

Infleunza

• 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

50USFDA

Influenza

RH

Malaria

TB

HIV


Inspections

0

5

10

15

20

25

30

35

40

2005 2006 2007 2008 2009 2010 2011

FPP

API

CRO

QCL


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


Technical assistance to applicants

• More than 80 technical assistance missions have been organized and delivered


Trainings

• More than 95 trainings have been delivered


The assessment process in more detail


The assessment teamHead of

Assessments

Quality assessors (API and FPP)

BE assessorsClinical assessors

(Clinical data and WHOPAR)

- More than 50 temporary advisors )pool of external assessors( - Six full time in-house and one rotational assessor.


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


Assessors tools

• WHO and other guidelines• Pharmacopoeias• Internal guides (alerts)• Previous assessment reports• Discussion with colleague assessors


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


Assessors working


• 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

http://www.who.int/prequal


Thank you

pqp-overview & update january 2012 1 prequalification of medicines overview & update...

Documents

standards pqpoverview

empqsmpqpoverview update

quality of procured

quality testing of products

quality control testing

apisreview of quality

generic medicines

efficacy of medicines