Ethiopian Food, Medicine and

Healthcare Administration
and Control Authority

EFMHACA
 Pharmaceutical Legal and Regulatory
Environment of Ethiopia
Heran Gerba, B.Pharm, MSc
Deputy Director General
EFMHACA
May 2016
Capital Hotel Hall, Addis Ababa

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 Outline of the Presentation
• Introduction
• The regulatory sector (Mission, vision, objectives and
system structure)
• Legal framework
• Core Functions of the Authority: Mandates
– Manufacturing inspection
– Registration
– Distribution channel regulation
• National strategy of local manufacturing

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 Introduction
• Primary healthcare coverage

• The public is demanding for

quality and safe healthcare • Keep me safe
services and products
• Heal me
• Be nice to me

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 Introduction

• Ethiopia has its own national health and

drug policy (Provision of essential
medicines, medical supplies &
equipments shall be strengthened)

• Health Sector development plan

• Regulatory Sector strategies

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 Introduction: Healthcare reform

REGULATOR

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Ethiopian health system organization/ tier system

Specialized Tertiary level healthcare

Hospital

§ General hospital
§ Specialty center Secondary level healthcare
§ Speciality clinic
Primary § Medium Clinic
hospital § Primary clinic

Health
center Primary level
healthcare
Health post
The regulatory
Sector

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 Mission, Vision and objectives
Mission
– 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 while promoting rational medicines use
Vision
– Quality health services and products to all Citizens

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 Mission, Vision and objectives con’t
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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 The Regulatory sector:
system structure
North Western Eastern Ethiopia Southern Ethiopia

REGIONAL
REGULATORY
BODIES [Region,
Zone and Woreda
level]

South Western Northern Ethiopia North Eastern

19 Port of Entry
and Exit

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 What to regulate: with regard
to Medicine?
Medicines

Supplies Biologicals

Medical equipment

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 Legal Framework
Proclamation 661/2009:-
• No medicine shall be produced locally or imported
and put in use unless it is duly registered by the
executive organ after being tested for its safety,
efficacy and quality.
• The certificate of registration of a medicine shall be
renewed every four years where the medicine
continues to meet the requirements of registration.

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 Legal cont……
Regulation 299/2013:-
ü Any medicine manufacturer or agent may only
manufacture or import a medicine that is included in
the national drug list. (Some circumstances may
allow)
ü The authority shall issue certificate of registration of
market authorization after:-
§ Assuring compliance to GMP
§ Medicine dossier evaluated and found to fulfill safety,
efficacy and quality requirements
§ The medicine fulfill laboratory quality test requirements

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 Main Functions of the regulatory
Authority
1. Marketing authorization and
product registration
2. Quality control laboratory testing
3. Good Manufacturing Practice
(GMP) inspections and licensing of
manufacturers
4. Importers, exporters, wholesalers
and other distribution channels
inspection and licensing
5. Port of entry and exit inspection
6. Storage and distribution inspec
7. Non-clinical and clinical trials
evaluation
8. Pharmacy practice inspection
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9. Control of advertisement and promotion
10. Ensuring proper disposal of
pharmaceuticals
11. Control of narcotics and psychotropic
substances
12. Provision of drug information and
promotion of rational drug use;
13. Pharmacovigillance
14. Post-marketing surveillance
15. Registration and licensing of pharmacy
professionals
17. Illegal medicine trade control like
Counterfeit, sub standards,
adulterations
16. Enforcement operations;
EFMHACA
 Medicine Registration
and quality assurance
con’t
• Premarket testing
• Consignment testing
• Sample from market testing

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 Medicine Registration and quality
assurance Con’t
• No medicine is allowed to enter to Ethiopia with out
the prior permission of the Authority

• The Authority may grant a special permit for the

import of medicine not registered for some
circumstances

• Pre import permission for each consignment

• Port of entry and exit clearance Authorization

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 Medicine Registration Con’t

• The Authority may grant a special permit for the import

of medicine not registered for the following purposes:
– Clinical trials or any other scientific investigations;
– Prescribed by physician for personal use of a patient;
– Laboratory quality test for registration;
– Natural or man-made disaster or similar emergency aid;
– Use of diplomatic missions; or
– Medicine lacking the motivation of importers or for medicine
used for the treatment of diseases not given adequate
attention.

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 Medicine Registration…

Current Registration System

ü Based on registration guideline with CTD format
ü Expedited registration process for companies
approved by stringent regulatory authorities
ü Fast track registration process for locally
manufactured medicines, HIV, TB, malaria, RH
products, oncology products.

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 Medicine Distribution channel
regulation
• The formal medicine
Indicator Data
distributions channels are
– Manufacturers Manufacturers 22
– Importers Importers & 600
– Wholesalers Wholesalers
– Retail outlets
(Pharmacy, drug store, RDV) Pharmacies 779
– Healthcare facilities
Drug stores 3201
– Port and exit inspection/
port clearance Rural drug 1081
vendor

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 Medicine Distribution channel
regulation
• No medicine establishment is operational without
prior permission of the regulatory bodies

• Licensing and inspection, based on specified

requirements, of the medicine distribution channels is
important

• The medicine distribution channels are regulated to

ensure good storage & distribution practices.[GDP,
GSP & Recall guidelines available]

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 Medicine Distribution channel
regulation Con't
• Post marketing surveillance: have been conducting
to ensure if the registered medicine maintains to
quality, safety and efficacy
• Pharmacovigilance
─ ADE reporting and safety monitoring
─ Periodic safety update reports (PSUR)
─ ADE analysis
─ Risk communication

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 Medicine Distribution channel
regulation Con't
Pharmacovigilance System
─ ADE reporting and safety monitoring
─ Periodic safety update reports (PSUR)
─ ADE analysis
─ Risk communication
• Prepaid ADR Yellow form
• On-line reporting using our
website
─ www.fmhaca.gov.et
• Phone
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 Medicine Distribution channel regulation
Con't

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 Medicine Distribution channel
regulation Con't

National PV Data
base which contains
•Adverse drug
reaction
•Medical error
• Product quality
defect

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 Public mobilization
• Public ownership in regulation

• Public mobilization to tackle

illegal trade

• Free phone call accessible to the

public

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 Legal instruments for regulation
con’t
• Medicine registration Guidelines

• Good Manufacturing Practice Guidelines

• Administrative Measure Taking and Complaint

Handling Directive No 8/2012

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 Legal instruments for regulation
con’t
• Medicine, medical equipment and supplies importer,
exporter and wholesaler control directive No 10/2013

• Precursor chemicals control directive No 18/2014

• Medical equipment donation directive No 9/2012

• Medicine donation directive No 6/2012

• Medicine advertisement and promotion Directive No
15/2013

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 Legal instruments for regulation
con’t
• STGs, 3rd Ed
• National Formularies, 2nd Ed
• Essential Medicine lists, 6th Ed
• Emergency medicine list, 1st Ed
• OTC Medicines List, 2nd Ed
• Categorized lists, based on level of care
• Pharmacovigillance guideline, 3rd Ed
• Prescribing and Dispensing Manuals, 2nd Ed
• Other directives and guidelines [see www.fmhaca.gov.et
www.fmhaca.gov.et]]

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 GMP guideline
• EFMHACA, GMP guideline
Main Principles, First Edition,
2014

• The guideline describes a

comprehensive quality
system model, which if
implemented will allow
manufacturers to support
and sustain robust, modern
quality systems consistent
with cGMP regulations.
 National Strategy for the Pharmaceutical
Man. Devt. In Ethiopia (2015-2025)
• GTP-I:- targets for the Pharmaceutical Industry
ü Achieve full utilization of the existing capacity of
local pharmaceutical and medical supplies
manufacturers.
ü Raise share of domestic market held by local
pharmaceutical and medical supplies manufacturers
to 50%
ü Increase the export earnings of pharmaceutical
and medical supplies manufacturers to
US$ 20 million per year.
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 National Strategy for the Pharmaceutical Man.
Devt. In Ethiopia (2015-2025)

• Government’s commitment:- Establishment of

FBPIDI:- development through accelerated
technological development and transfer by
providing comprehensive, innovative,
knowledge based and accessible
support……………import substitution as
well as exports

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 National Strategy Cont…..
Import Research &
Formulation
Packaging & Development
Distribution of finished Production for new
Labeling of
of imported products from of APIs & formulations,
imported bulk
finished imported APIs Excipients processes &
finished
pharmaceut & excipients new chemical
products
ical Level 4 entities
products Level 3
Level 2 Level 5
Level 1

FOLLOWING NATIONAL/INTERNATIONAL GMP STANDARDS , GLP, GCP and ETHICAL

STANDARDS

Majority of the players in the Eth. Pharmaceutical sector are at

Level 1………..they import finished formulations.

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 National strategy cont….
• The strategy details on how to transform the pharmaceutical
sector in Ethiopia
Seven strategic objectives:-
• Strategic Objective 1:- Improve access to medicines through quality
local production- implement the GMP roadmap
• Strategic Objective 2:- Strengthen the national medicine regulatory
system
• Strategic Objective 3:- Create incentives designed to move companies
along the value chain
• Strategic Objective 4:- Develop human resources through relevant
education & training
• Strategic Objective 5:- Encourage cluster development and production
of APIs
• Strategic Objective 6:- Create a research & development Platform
• Strategic Objective 7:- Attract foreign direct investment in the
pharmaceutical sector
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 National Strategy for the Pharmaceutical Man. Devt. In
Ethiopia (2015-2025)
• Selected Indicators of Progress & targets
Indicator Current 2020 2025
Pharmaceutical Manufacturers with int. GMP 2 5 20
Essential medicines purchased by PFSA from local manufacturer’s (%) 20 50 60
No. of WHO prequalified products produced locally 0 4 15
New manufacturing companies and local capital invested 0 5 11
Joint ventures with international GMP compliant companies 3 8 15
API manufacturers 0 1 3
Export of locally produced medicines by GMP compliant producers 2 30 80
(US $ million)
Phase IV clinical trials conducted in Eth. 0 10 30
Phase II & III clinical trials conducted in Eth. 0 3 10
BE study conducted by BE centre 0 10 25
Bioavaialability study of available essential medicines 0 18 30

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 National Strategy for the Pharmaceutical Man.
Devt. In Ethiopia (2015-2025)

Indicator Current 2020 2025

Locally developed TMs on the market 0 5 20
Natural products with identified APIs - 80 160
Clinical trials conducted on TMs 0 3 20
Incubators 0 1 3
No. of graduates in industrial 0 200 1500
pharmacy and reg. affairs
Courses established in QA/control, 0 10 50
GMP, management & enterpreneurship

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 Pharmaceutical industry
• FACTORS CONTRIBUTING TO PHARMACEUTICAL INDUSTRY
GROWTH
Demographic
Growing
trends & rising
Consumerism
medical needs

Pharmaceutical
Industry
Stable Growth Maturing Regulatory
Environment
macroeconomic
growth

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 For further reference navigate
www.fmhaca.gov.et

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Quality health services and products to all Citizen EFMHACA
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