1. 1 |1 | WHO Prequalification – Medicines Assessments Andrew Chemwolo, Technical Officer Prequalification Team – Medicines Assessment

2. 2 |2 | Medicines Assessment  Group within PQT involved in assessment of applications for medicines prequalification.  Only product dossiers for medicines included in the Invitation for Expression of Interest (EOI) are considered for prequalification

3. 3 |3 | Invitation for Expression of Interest (EOI)  Contains a list of medicines invited for prequalification  Priority public health medicines  List prepared by WHO clinical experts/departments (HIV, TB, Malaria, RH, Influenza, Diarrhoea (Zinc), NTD)  Based on inclusion in WHO treatment guidelines and/or WHO model list of essential medicines  EOIs are published on WHO PQ web site  List revised as needed to capture new developments

4. 4 |4 | Therapeutic areas  Therapeutic areas invited are:  HIV/AIDS, including hepatitis B & C  Malaria  Tuberculosis  Reproductive Health (RH)  Influenza  Acute diarrhoea in children (zinc)  Neglected Tropical Diseases (NTDs)

5. 5 |5 | Current Expressions of Interest Currently 8 EOIs are published:  HIV/AIDS, including hepatitis B & C – 12 th  Influenza – 2 nd  Malaria – 11 th  Neglected Tropical Diseases (NTD) – 3 rd  Reproductive Health – 6 th  Tuberculosis – 12 th  Diarrhoea (Zinc) – 1 st  Active Pharmaceutical Ingredients – 7 th

6. 6 |6 | Prequalification process Expression of Interest Acceptable Additional information and data Corrective actions Compliance Assessment Inspections Prequalification Maintenance and monitoring Product dossier + Site Master File

7. 7 |7 | Prequalification of medicines  Common prequalification process for all therapeutic areas.  Stages:  Receipt of application  Screening and acceptance for assessment  Assessment of Quality and Efficacy/Safety data  Inspection of manufacturing sites (FPP, API) and CROs  Prequalification/listing  Maintenance/Monitoring of the products after prequalification Variations, Requalification, Inspections, Random QC sampling, Investigation of complaints etc.

8. 8 |8 | Dossier assessments  Quality and Efficacy/Safety parts of dossier assessed in parallel  Several rounds of communication with applicants  QA step at the end of the assessment process  Close coordination with inspectors  Product listed (prequalified) once all requirements are met and letter of prequalification issued to applicant.

9. 9 |9 | Dossier assessments…  WHO, ICH, specific PQ guidelines and recognized pharmacopoeias are applied  All the relevant guidelines and forms published on WHO PQ web site (http://www.who.int/prequal/)http://www.who.int/prequal/  Abbreviated process for prequalifying medicines approved by a stringent regulatory authority (SRA) to avoid duplication

10. 10 | Paths for inclusion of a product in the list of prequalified products  Prequalification of multisource generic products  Full review of dossier and inspection of sites by WHO PQ  Prequalification of innovators  Approval based on marketing authorization issued by an SRA  Prequalification of generic products approved by an SRA  Approval based on SRA marketing authorization  Recognition of temporary approvals / scientific opinions  USFDA PEPFAR approval/tentative approval  EMA article 58  Health Canada Access programme

11. 11 | Requalification  Review after five years from the date of prequalification of the product, or when requested to do so by WHO PQ (whichever date is earlier)  Procedure applicable to products fully assessed and prequalified by WHO PQ.  Purpose of requalification:  Ensure that the listed products conform to current norms and standards.  Follow up on commitments made at time of prequalification

12. 12 | API Prequalification  Started as a pilot project in October 2010.  It is a scheme for manufacturers of APIs that are used in invited medicinal products (current 7 th EOI).  It seeks to verify and identify APIs that are of good quality and manufactured in compliance with GMP.  Involves assessment of the APIMF and inspection of manufacturing sites.

13. 13 | API prequalification  List of prequalified APIs published on the WHO PQ web site  Applicants with prequalified APIs are issued with a WHO Confirmation of API Prequalification document.

14. 14 | WHO Public Assessment Report (WHOPAR)  Aims to make assessment outcomes publicly available  Composed of 8 parts, including those for SmPC, PIL & Labelling  Report summarizes assessment of the product data and information submitted in the product dossier (excluding confidential/proprietary information).  Reports published on the WHO PQ web site  Updated regularly

15. 15 | Web site: http://www.who.int/prequal/

16. 16 | Products under assessment

17. 17 | Further information: Further information: http://www.who.int/prequal/ http://www.who.int/prequal/ Email: prequalassessment@who.int or stahlm@who.int (Dr. Matthias Stahl)prequalassessment@who.int stahlm@who.int

18. 18 | Thank you!