rmnch medicines in every woman every child countries survey results on regulatory and procurement...

RMNCH Medicines in Every Woman Every Child Countries

Survey results on Regulatory and Procurement Status

Lisa Hedman Deus Mubangizi

Robinah NajjembaWorld Health Organization

RMNCH TRT, April 2014, New York

Objective: to clarify the regulatory and procurement

status of life-saving commodities in EWEC countries

RMNCH medicines in EWEC countries April 2014, New York 3 |

Modules from the RMNCH landscape tool

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

MethodsMethods


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

Regulatory status

Registration status: UNCoLSC RH commoditiesRegistrations: RH

Registration status of Maternal Health Lifesaving Commodities in 21 EWEC countriesRegistrations: Maternal Health

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

Registration Status of Child Health Commodities in 21 EWEC CountriesRegistration: Child


Commodity Total registered mfg

Levonorgestrel 75mg Implant

8

Levonorgestrel 1.5mg tablet

16

Levonorgestrel 0.75mg tablet

25

Registered manufacturers: RHRegistered manufacturers: RH



Oxytocin inj. 10IU 36

Misoprostol 200mcg

tablet

21

Magnesium sulfate

500mg injection

16

Registered manufacturers: Maternal Health Registered manufacturers: Maternal Health



Gentamicin 40mg per ml 103

Procaine penicillin 1 g vial 17

Ampicillin Injection 250mg, 500mg

or 1g

108

Ceftriaxone 250mg, 500mg or 1g 282

Betamethasone inj. 4mg per ml 9

Dexamethasone inj. 4mg per ml 59

Chlorhexidine 4% gel or solution 2

Registered manufacturers: Newborn Registered manufacturers: Newborn



Amoxicillin 250 or 500mg dispersible

tablets36

Oral Rehydration Salts 50

Zinc sulfate 10mg or 20mg dispersible

tablets20

Registered manufacturers: Child Registered manufacturers: Child


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

Procurement status

RH lifesaving commodities included in the EMLs of 11 EWEC Countries

EML Status: RH

EML Status: Maternal

New born Health lifesaving commodities included in EMLs of 11 EWEC countries

EML Status: Newborn

Child Health lifesaving commodities included in EMLs of 11 EWEC Countries

EML Status: Child


Current activities

a) Medicine Quality Assurance System (MQAS) and assessment tools for procurement agencies

b) Pricing Guidelines (including supply chain markups)

c) ERP for quality assurance in procurement

SummarySummary

rmnch medicines in every woman every child countries survey results on regulatory and procurement...

Documents