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 Ethiopian Food, Medicine and Healthcare Administration and Control Authority was established since 2010. IT replaces the former DACA; which was responsible to regulate medicine only. 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 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 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 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

1. Ethiopian Food, Medicine and
Healthcare Administration
and Control Authority
EFMHACA

2. 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

3. 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

4. Quality health services and products to all Citizen EFMHACA
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

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

6. 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

7. Quality health services and products to all Citizen EFMHACA
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

8. Quality health services and products to all Citizen EFMHACA
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

9. Quality health services and products to all Citizen EFMHACA
• 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

10. Quality health services and products to all Citizen EFMHACA
18 Port of
Entry and Exit
REGIONAL
REGULATORY
BODIES [Region,
Zone and Woreda
level]
Organization of EFMHACA
Kombolcha
Branch

11. Quality health services and products to all Citizen EFMHACA
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

12. Quality health services and products to all Citizen EFMHACA
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)

13. Quality health services and products to all Citizen EFMHACA
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)

14. Quality health services and products to all Citizen EFMHACA
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

15. Quality health services and products to all Citizen EFMHACA
Organization of EFMHACAOrganization of EFMHACA
Advisory
Board
Advisory
Board

17. Quality health services and products to all Citizen EFMHACA
Profile: Human ResourcesProfile: Human Resources

18. Quality health services and products to all Citizen EFMHACA
Profile: DetailProfile: Detail
• 8 Technical directorates
• 8 Supportive directorates
• 7 Branch offices
• 18 Entry and exit ports

19. Quality health services and products to all Citizen EFMHACA
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

20. Quality health services and products to all Citizen EFMHACA
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

21. Quality health services and products to all Citizen EFMHACA
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.

22. Quality health services and products to all Citizen EFMHACA
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

23. Quality health services and products to all Citizen EFMHACA
National Policy, Strategies andNational Policy, Strategies and
PlansPlans

24. Quality health services and products to all Citizen EFMHACA
PoliciesPolicies
• National health policy
• National drug policy

25. Quality health services and products to all Citizen EFMHACA
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)

26. Quality health services and products to all Citizen EFMHACA
National
Regulatory Infrastructures

27. Quality health services and products to all Citizen EFMHACA
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

28. Quality health services and products to all Citizen EFMHACA
Lab Certification:Lab Certification:
ISO 17025ISO 17025
• Premarket testing
• Consignment testing
• Sample from market
testing
• Condom lab: certified

29. Quality health services and products to all Citizen EFMHACA
Website: www.fmhaca.gov.et

30. Quality health services and products to all Citizen EFMHACA
Medicine Registration Information system

31. Quality health services and products to all Citizen EFMHACA
Health Professionals Information System

32. Quality health services and products to all Citizen EFMHACA
Laws and regulations

33. Quality health services and products to all Citizen EFMHACA
Thank you