1. Strengthening the impact of the WHO prequalification program April 28, 2007

2. Session Objectives Objectives: Update on progress with hormonal contraceptive prequalification Update on the prequalification process for devices: condoms and IUDs Discussion on effectively linking prequalification to commodity funding and country-level work

3. Anticipated outcomes of the prequalification process: Improved access to low-cost generics Consistent product quality standards In-country manufacturing capacity strengthened and regulatory awareness raised Prequalification Project

4. Prequalification Process Steps Publication of Invitation for Expression of Interest (EOI) Screening of dossiers Dossier assessment Site audit Product testing Manufacturers listing Monitoring Re-qualification

5. Case Study Expansion of the supplier base Significant price reductions In-country industrial capacity building

6. Device Prequalification Status of Condom program Status of IUD program

7. Hormonal Contraception EOI October 2006 Expression of Interest for: Ethinylestradiol + Levonorgestrel tablet Levonorgestrel, tablet 30 micrograms, 750 micrograms (pack of 2), 1.5 mg (pack of 1) DMPA 150 mg/ml 9 responses received to date Initial review not promising 3–5 prequalified manufacturers likely by 2008

8. Core list of RH medicines for priority prequalification clotrimazole latex male condoms ethinylestradiol + levonorgestrel copper-bearing intrauterine contraceptive devices (IUD) levonorgestrel for oral hormonal contraception levonorgestrel for emergency contraception magnesium sulfate medroxyprogesterone acetate (DMPA) depot injection oxytocin Already in WHO’s prequalification program azithromycin cefixime

9. Supporting the prequalification program Incorporate WHO prequalified sources in direct institutional procurements Adopt procurement policy similar to the Global Fund Include the requirement in funding agreements for recipients to use WHO prequalified sources

10. Raising awareness of the prequalification program Promote the benefits already gained by the inclusion of RH medicines in the WHO program to home organizations Orient country level colleagues to the prequalification program as it relates to RH supplies

11. Key messages for home organizations RH Prequalification program: Built on existing WHO program Ensures quality Drives lower costs Strengthens in-country manufacturing capacity Broad support from international stakeholders

12. Messages for home organizations Encourage your suppliers to participate in WHO/UN prequalification progamme and submit dossiers Inform all your suppliers officially that you will procure prequalified products as soon as two products have been prequalified Inform your local suppliers that WHO can provide technical advice to prepare for prequalification and improve quality where needed Main message: prequalification is a global support mechanism to improve their quality production, and will establish international export potential

13. Key messages for country-level colleagues Prequalification program: Ensures quality Facilitates access to quality products Reduces cost of quality assurance Drives lower product costs Strengthens in-country manufacturing capacity Is part of a donor trend toward using prequalified sources

14. Open Discussion Are you able to pursue these implementation steps? Do you anticipate any concerns or constraints? Share your experiences at the RHSC October meeting. WHO Prequalification Web site http://www.who.int/prequal