Ethiopian Food, Medicine and
Healthcare Administration
and Control Authority
EFMHACA

Quality health services and products to all Citizen EFMHACA
Establishment, Organization andEstablishment, Organization and
the Role of EFMHACAthe Role of EFMHACA
Kidanemariam G/Michael; Bpharm, MBA, MPH
Pharmaceutical Regulation Advisor
February 2018
Executive International Hotel
Adama, Ethiopia

Quality health services and products to all Citizen EFMHACA
Outline of the PresentationOutline of the Presentation
• Introduction
• Overview on history of regulation in Ethiopia
• Establishment of EFMHACA
• Organization of EFMHACA
• Mission, vision and objectives
• What we regulate
• Role of EFMHACA
• National policy, strategies and plans
• National regulatory infrastructures

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IntroductionIntroduction
• Health services and products are the most
stringently regulated in the world.
• The current regulation represents the distilled
wisdom of past experiences.
• Having safe and quality products and services is a
corner stone for public health

Quality health services and products to all Citizen EFMHACA
Overview on History of Regulation in Ethiopia

Quality health services and products to all Citizen EFMHACA
Overview on History of Regulation in Ethiopia
• Organized regulation started since 1960s
• Health Sector Reform [in 2008]; which scrutinizes all
regulatory components together
• Mandate were divided into [in 2009)
– Federal regulatory body
– Regional regulatory bodies

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Overview on History of Regulation in Ethiopia
• EFMHACA Comes into picture [in 2010]
– Foods
– Medicines
– Medical Devices
– Cosmetics
– Health services
– Health professionals
– Other health products

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Establishment of EFMHACAEstablishment of EFMHACA
• EFMHACA is a federal science based law enforcement
authority mandated to protect the public health and
safety
– Established by Council of Ministers Regulation No.
189/2010
– Established as an autonomous government office
having its own legal personality
– Accountable to Ministry of Health
– Head office at Addis Ababa and may have branch
office else where, as may be necessary

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• Title: The Food, Medicine and Healthcare Admin and
Control Authority Establishment Council of Ministers
Regulation No. 189/2010
• It has 17 articles
• Effective since 23rd
august 2010
The Food, Medicine and Healthcare Admin andThe Food, Medicine and Healthcare Admin and
Control Regulation No. 189/2010Control Regulation No. 189/2010

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18 Port of
Entry and Exit
REGIONAL
REGULATORY
BODIES [Region,
Zone and Woreda
level]
Organization of EFMHACA
Kombolcha
Branch

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Regional regulatory bodies organization
• Agency/Authority
– Addis Ababa Food, Medicine and Healthcare Administration
and Control Authority
– Somalia Food, Medicine and Healthcare Administration and
Control Agency
– Gambella Food, Medicine and Healthcare Administration
and Control Agency
– SNNPR Health and health related services and products
quality assurance authority

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Regional regulatory bodies organization con.t
• Core processes
– Health and health related services and products core
process (Tigrai)
– Health and health related services and products core
process (Amhara)
– Health and health related services and products core
process (Oromia)
– Health and health related services and products core
process (Afar)
– Health and health related services and products core
process (Benishangul Gumz)

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Regional regulatory bodies organization con.t
• Core processes
– Health and health related services and products
core process (Diredawa)
– Health and health related services and products
core process (Harar)

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Organization of EFMHACA
• The Authority shall have
– An advisory board
– A director general and deputy director generals to
be appointed by the government
– Necessary staffs
• Structure
– Administrative wing
– Enforcement wing

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Organization of EFMHACAOrganization of EFMHACA
Advisory
Board
Advisory
Board

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Profile: Human ResourcesProfile: Human Resources

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Profile: DetailProfile: Detail
• 8 Technical directorates
• 8 Supportive directorates
• 7 Branch offices
• 18 Entry and exit ports

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Mission, Vision and objectives
Mission Statement
– To promote and protect the public health by
ensuring safety and quality of products and health
service through
• registration, licensing and inspection of health
professionals, pharmaceuticals & food
establishments, and health facilities and
• provision of up-to-date regulatory information
• promoting rational medicines use

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Mission, Vision and objectives Con’t
Vision
– Quality health services and products to all citizens
Objectives
To protect the health of consumers by ensuring:
─ Food safety and quality
─ Safety, efficacy, quality and proper use of medicines
─ Competence and ethics of health professionals
─ The standards of health institution and
─ The hygiene and environmental health protection
suitability for individuals and community health

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What we regulateWhat we regulate
Practices
•Healthcare service at all levels
•Quarantine services at port of entry
& exit
Premises
•Food Establishments
•Pharmaceutical Establishments
•Health & Health related Facilities
•Entry and exit Ports
Professionals
•All type of Health professionals
─ Lower level
─ Middle level
─ Higher level
Products
•Food products
•Medicines
•Medical devices and supplies
•Laboratory reagents
•Cosmetics etc.

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Role of EFMHACARole of EFMHACA
• Pre-market evaluation and
registration
• Re-registration approval
• Variation evaluation & approval
• Clinical trial authorization and
monitoring
• Community Mobilization
• Free toll information dissemination
• Online information access
• Education material disseminate
• Alert systems
• Inspect premises like factory
• Licensing of Manufacturers,
Importers & Wholesalers
• Market survey
• Analysis of samples
- pre- and post-registration products
- Testing of complaint cases
- Post market testing
• Post-registration market
surveillance
• Collect samples
• Samples lab testing
• ADE monitoring
• Quality defect
• Medical error
22

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National Policy, Strategies andNational Policy, Strategies and
PlansPlans

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PoliciesPolicies
• National health policy
• National drug policy

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Current National Strategies and PlansCurrent National Strategies and Plans
• Health sector transformation plan
(2015/16-2019/20)
• Health regulatory sector transformation
plan (2015/16-2019/20)
• National nutrition strategy (2008)

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National
Regulatory Infrastructures

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Health regulatory information centerHealth regulatory information center
• Public ownership in regulation
• Information provision via free
call service
– Food safety and quality
– Medicine rational use
– Health service
– Any illegal act on food, medicine,
health service

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Lab Certification:Lab Certification:
ISO 17025ISO 17025
• Premarket testing
• Consignment testing
• Sample from market
testing
• Condom lab: certified

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Website: www.fmhaca.gov.et

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Medicine Registration Information system

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Health Professionals Information System

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Laws and regulations

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Thank you