WHO update on:

1. WHO update on: Guidelines for the selection of RH medicines and prequalification of priority RH medicines RHSC meeting, New York 27-28 April 2006 Medicines Policy and StandardsHealth Technology and Pharmaceuticals Cluster 1

2. Outline • Interagency lists of essential medicines and medical devices for reproductive health • The PATH/WHO/UNFPA practical guideline for inclusion of essential medicines for RH on national medicines lists • WHO prequalification project for priority RH medicines

3. Interagency list of essential medicines for RH, 2006 • Published and in distribution process • Systematic review of contraceptive medicines initiated: review of evidence supporting the value of the choice philosophy vs the selection approach of the WHO Expert Committee- final in August 2006 • New applications for addition, changes and/or deletion of medicines in the WHO Model List to be submitted by October 2006 (next meeting of the committee March 2007) • Comments and suggestion on the Interagency list essential medicines for RH welcomed

4. Interagency list of essential medical devices for RH, 2006 • Achieving consistency in the minimum list of medical devices and supplies for common interventions in maternal and RH, including HIV/AIDS commodities • Drafted after 4 interagency consultations: • By group of items, according to MNH interventions • Use UNICEF nomenclature (UNCCS) • Sent for final review process and will be completed by June 2006 • The list will include a glossary of definitions/specifications

5. Outline • Interagency lists of essential medicines and medical devices for reproductive health • The PATH/WHO/UNFPA practical guideline for inclusion of essential medicines for RH on national medicines lists • WHO prequalification project for priority RH medicines

6. Practical guideline for inclusion of essential medicines for RH on national medicines lists • Practical information for all stakeholders at national level to facilitate the integration of medicines for RH into national list • Include 16 medicine briefs, as examples, that gather essential evidence • Field testing of this version planned in 2 countries • Support of the RHSC members in its implementation is crucial

7. Outline • Interagency lists of essential medicines and medical devices for reproductive health • The PATH/WHO/UNFPA practical guideline for inclusion of essential medicines for RH on national medicines lists • WHO prequalification project for priority RH medicines

8. WHO prequalification project for priority RH medicines • Core list of priority medicines developed and shared with the subgroup on generic manufacturers (January 06) and prior the NY meeting for general agreement • Advocacy of the prequalification process to manufacturers by RHSC is key to increase its value • Experience in past years of prequalification project: • "> 70% of manufacturing sites did not pass in first inspection and > 80% dossiers evaluated do not meet requirements"

9. WHO prequalification project for priority RH medicines Next steps: • Core list of priority medicines completed • Support of partners as advocate and agreement to use the outcomes of the PreQ • EOI posted on the PreQ website

10. http://mednet3.who.int/prequal/

11. WHO Prequalification project - Principles • Voluntary for participating manufacturers • Based on sound standards - General procedure and standards approved through WHO Expert Committee system involving all WHO Member States and WHO Governing bodies • Widely discussed • Supported by ICDRA in 2002 and 2004, representing more than 100 national drug regulatory authorities • Transparent (all information available on the web site http://mednet3.who.int/prequal/) • Open to innovators and multisource/generic manufacturers • No costfor applicants – to date

12. Objectives • Propose list of prequalified products linked to manufacturing site for quality, efficacy and safety have been assessed, inspected and controlled to meet international norms and standards • Give assurancethat international norms and standards are applied at all the steps of the prequalification and at the process itself • Enable and speed up accessto good quality of medicines

13. Objectives - continued • Follow-up and regular monitoring of the quality of manufacturers and products • Ensure re-qualification and update of the list of prequalified products and manufacturers as new products and manufacturers meet the standards • Ensure the appropriate control of variations and changes

14. Objectives - continued Develop the local capacity for quality production • National regulatory authorities (NRA) are involved in dossier assessment and inspections • Producers receive invaluable specific technical feedback • Helpthe national NRA to build up capacity in assessment, inspection and control meeting international norms and standards

15. Steps of prequalification 1. Expression of interest (EOI)from a prospective supplier interested in a voluntary participation in the program. 2. Explicative notes and guidelines published on WEB in order to explain how to prepare a product dossier meeting requirements for prequalification. 3. Receipt of the dossierat UNICEF in Copenhagen and Site Master File in WHO Geneva • Screening of the dossier, "Quality" part, "Clinical" part and samples Listed for the possible inspection 5. Assessment of the dossier and writing of assessment report and assessment letter 6. Outcome of evaluation communicated to supplier

16. Steps of prequalificationcont… 7. Inspection of manufacturing site(s) and follow-up inspection when necessary  GMP compliant list of manufacturers 8. Inspectionof Research Laboratory or Contract Research Laboratory (CRO) where bioequivalence study has been performed  GCP compliant list of CROs 9. Conclusion and listing of product in prequalification list 10. Publication of Public Assessment and Inspection Reports 11. Assessment of the variation when submitted, market survey, de-listing, if necessary 12. Re-qualification after 3 years