1. PQP-overview & update January 2012 1 Prequalification of Medicines Overview & update Wondiyfraw Z. Worku WHO Prequalification of Medicines Programme Assessment training, Copenhagen January 2012

2. PQP-overview & update January 2012 2 Agenda PQP and its activities PQ process flow Some numbers and achievements The Assessment team

3. PQP-overview & update January 2012 3 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

4. PQP-overview & update January 2012 4 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.

5. PQP-overview & update January 2012 5 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

6. PQP-overview & update January 2012 6 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.

7. PQP-overview & update January 2012 7 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

8. PQP-overview & update January 2012 8 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)

9. PQP-overview & update January 2012 9 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

10. PQP-overview & update January 2012 10 Process flow Application for prequalification Dossier, Samples & SMF Screening Applicant GMP Review of GMP Certification, Inspection reports, Site Master Files (SMF). Information requested Application accepted for assessment Assessment Accepted Applicant Manufacturer Inspection Corrective and preventative actions Final decision on prequalification Listing on WHO website Variations Complaints Random sampling Requalification Information requested Information requested Expression of interest (EOI) WHOPIR WHOPAR

11. PQP-overview & update January 2012 11 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

12. PQP-overview & update January 2012 12 List of products included in WHO prequalified products list Prequalified generics and innovators as of December 31 st 2011: 274 products (assessed and inspected by PQ) Total listed as of December 31 st 2011 (including those listed based on USFDA/EMA/HCnda approvals): 366 products

13. PQP-overview & update January 2012 13 Inspections

14. PQP-overview & update January 2012 14 Prequalified / interested laboratories December 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

15. PQP-overview & update January 2012 15 Technical assistance to applicants More than 80 technical assistance missions have been organized and delivered

16. PQP-overview & update January 2012 16 Trainings More than 95 trainings have been delivered

17. PQP-overview & update January 2012 17 The assessment process in more detail

18. PQP-overview & update January 2012 18 The assessment team Head 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.

19. PQP-overview & update January 2012 19 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

20. PQP-overview & update January 2012 20 Assessors tools WHO and other guidelines Pharmacopoeias Internal guides (alerts) Previous assessment reports Discussion with colleague assessors

21. PQP-overview & update January 2012 21 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

22. PQP-overview & update January 2012 22 Assessors working

23. PQP-overview & update January 2012 23 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

24. PQP-overview & update January 2012 24 Thank you