1. RMNCH Medicines in Every Woman Every Child Countries Survey results on Regulatory and Procurement Status Lisa Hedman Deus Mubangizi Robinah Najjemba World Health Organization RMNCH TRT, April 2014, New York

2. Objective: to clarify the regulatory and procurement status of life-saving commodities in EWEC countries

3. TBS Geneva, November 2014 3 |3 |  Modules from a commonly developed tool by partners in the RMNCH  Distributed in Excel and on-line format  Distributed to 49 EWEC National Medicines Regulatory Agencies (NMRA) and Central Medical Stores (CMS)  Collection and review of available registers from respondent NMRAs Methods

4. TBS Geneva, November 2014 4 |4 |  Full or partial responses received and analyzed from 21 countries (43%)  Most responding countries required assistance to complete the survey  Some responses included copies of all registered medicines Regulatory status

5. Registration status: UNCoLSC RH commodities Registrations: RH

6. Registration status of Maternal Health Lifesaving Commodities in 21 EWEC countries Registrations: Maternal Health

7. Registration status of Newborn health lifesaving Commodities in 21 EWEC Countries Registration: Newborn

8. Registration Status of Child Health Commodities in 21 EWEC Countries Registration: Child

9. TBS Geneva, November 2014 9 |9 | CommodityTotal registered mfg Levonorgestrel 75mg Implant 8 Levonorgestrel 1.5mg tablet 16 Levonorgestrel 0.75mg tablet 25 Registered manufacturers: RH

10. TBS Geneva, November 2014 10 | CommodityTotal registered mfg Oxytocin inj. 10IU36 Misoprostol 200mcg tablet 21 Magnesium sulfate 500mg injection 16 Registered manufacturers: Maternal Health

11. TBS Geneva, November 2014 11 | CommodityTotal registered mfg Gentamicin 40mg per ml103 Procaine penicillin 1 g vial17 Ampicillin Injection 250mg, 500mg or 1g 108 Ceftriaxone 250mg, 500mg or 1g282 Betamethasone inj. 4mg per ml9 Dexamethasone inj. 4mg per ml59 Chlorhexidine 4% gel or solution2 Registered manufacturers: Newborn

12. TBS Geneva, November 2014 12 | CommodityTotal registered mfg Amoxicillin 250 or 500mg dispersible tablets 36 Oral Rehydration Salts50 Zinc sulfate 10mg or 20mg dispersible tablets 20 Registered manufacturers: Child

13. TBS Geneva, November 2014 13 |  Full or partial responses received and analyzed from 11 EWEC countries (22%)  Responses were more limited  Questions were reviewed for fitness of purpose and several recommended for modification Procurement status

14. RH lifesaving commodities included in the EMLs of 11 EWEC Countries EML Status: RH

15. EML Status: Maternal

16. New born Health lifesaving commodities included in EMLs of 11 EWEC countries EML Status: Newborn

17. Child Health lifesaving commodities included in EMLs of 11 EWEC Countries EML Status: Child

18. TBS Geneva, November 2014 18 | EML and regulatory status did not directly correlate to procurement availability Use of large wholesalers to impact markets not likely to be useful as an access lever in the responding countries Strong presence of certain products may be related to: –Demand generation activities –International commodity funding –Other considerations Conclusions

19. TBS Geneva, November 2014 19 | Country markets can consolidate demand around correct formulations and quality products through: –Updates to NEML developed in collaboration –Coordination of procurement options (not necessarily pooled procurement) Promote quality assurance strategies that are consistent and clear –Oxytocin labels might benefit from change, but requires evidence and a consolidated approach –Incorporate quality assurance measures into supply chain Strategies to stabilize markets

20. TBS Geneva, November 2014 20 | Streamline regulation to facilitate multi-country distribution and stability: –Develop model dossiers to avoid duplication in multiple countries –Review dossiers together as regulators to benefit from sharing resources Streamline upstream from regulation and identify procurement requirements that address quality and safety, not just low price –Regulators will not be able to harmonize or streamline if procurement continues to be segmented Strategies to stabilize markets

21. TBS Geneva, November 2014 21 | THANK YOU