Provides an overview of regulation of medical products in Kenya and the opportunities

1. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Kenya Pharmaceutical Sector,
Regulatory Overview and
Opportunities
Anthony Toroitich
Head, Trade Affairs,
Pharmacy & Poisons Board
1
18th August 2016
Hilton Hotel, Nairobi

2. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Outline
• Introduction
• Medical Products Regulatory Framework in Kenya
• Registration/Listing of Medical products regulated by
PPB
• Regulation of Personnel/Premise
• Selected Key Achievements and Areas of Improvement
• Medical Product Market Overview
• Manufacturing Opportunities
• Areas of Cooperation
• Conclusion
2

3. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Introduction
• Medical Products form a major
part of an effective healthcare
system
• Medical Product regulation has
developed over the past 50
years in response to crises
• Kenyan Constitution:
- Article 26(1): Guarantees life
- Article 43 (1): Aims at Universal
health coverage
• Business interest should not
impede access to healthcare to
innocent patients
3

4. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Pharmacy and Poisons Board
• National Medicines Regulatory
Authority – PPB.
– Pharmacy and Poisons Act, Cap 244, Laws
of Kenya
– Commencement Date: 1st of May 1957
• Vision: Center of excellence in
regulation of Pharmacy
Profession, Medical Products and
Technologies.
• Mission: Protection of the public
health by regulation of pharmacy
profession and ensuring Quality,
Safety and Efficacy of Medical
Products and Technologies.
4

5. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Regulatory Framework in Kenya
• Involves regulation of;
– Medical Products: Pre-market & Post-market Activities
– Profession: Personnel and Practice
– Premise: Licensure
• Details Pharmacy and Poisons Board website
www.pharmacyboardkenya.org
5

6. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Medical Products Regulatory
Framework
• Pre-market Regulation
– Clinical trials
– Registration/Listing of
Medical Products
– Inspection
• Post-Market Regulation
– Regulation of Medical
Information
– Regulation of Imports/Exports
– Good Distribution Practice
– Inspection, Surveillance and
Enforcement
Concep7on &
Development
Manufacture
Packaging &
Labeling
Adver7sing Sale Use Disposal
Pre-market
Placing on
Market
Post-Market
Surveillance
• Must comply with regulatory requirements to
assure Quality, Safety and Efficacy
• Post Approval Commitments
Safety and
Performance in
Market
6

7. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Medical Products regulated by PPB
Borderline products
Blood & Blood
products
Medical Devices and
Dietary Supplements Biological products
Medicines (Human &
Vet.)
7
• Regulatory standards
- Development
- Implementation
- Monitoring
- Enforcement
• Pre-market evaluation
& approval

8. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Marketing Authorization Process
• Screening
• Scheduling of Dossiers on
First In-First Out (FIFO) basis.
• Timeline for review within 12
mths (Normal) or 3 mths
(Priority).
• Processing fee @ submission
– USD 1000 (foreign), 500 (local)
– GMP Inspection: USD 4000
– Lab Analysis: USD 500-1000
• Response to Queries.
• Post-Marketing Actions
– Annual Retention
– Post Market variations
– Pharmacovigilance
Screen
Scheduling
Evalua=on
Approval
No
Yes
Yes
Submission
Yes
Queries
Yes
No
Yes
No
Yes
Post Marke=ng Ac=ons
8
Reject
Appeal

9. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Regulation of Personnel
• Regulation of Training
– Accreditation of training institutions
– Inspection and Licensure of training institutions
• Pre-registration
– Stage I Examination: Done twice per annum
– One year Internship
– Stage II Examination: Done twice per annum
• Annual Practice and Continuous Professional
Education
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10. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Regulation of Premise
• Licenses for Retail,
Wholesale and
Manufacturers
• Inspection,
surveillance and
enforcement
10

11. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Selected Key Achievements
• National Pharmacovigilance system in Kenya
• Centre of Excellence in Pharmacovigilance in Africa
• Established of Post Marketing Surveillance (PMS) system
• East African Medicine Regulatory
Harmonization
• Automation of Processes
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12. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Medical Product Market Overview
Year
Estimated
FOB Market
Size Value
USD
Estimated
FOB Value
USD
(IMPORTS)
Estimated
FOB Value
USD
(EXPORTS)
2013/2014 546,000,000 454,000,000 92,000,000
2014/2015 700,000,000 595,000,000 105,000,000
2015/2016* 894,000,000 763,000,000 131,000,000
*Expected projection by July 2016
• Highly Competitive and Fragmented
• Regulated Market
• Driven by Public and Private Sector
• Over 60 % from Imports from
Majorly India and China
• 30% locally Manufactured
Country/Region Import Market Share
India 60%
Europe 25.5%
China 4%
South Africa 4.5%
Japan 0.06%
South Korea 1%
EAC 1%
Others About 4%

13. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Manufacturing Opportunities
Country
# of
Manufacture
Population Ratio
India 30000 1.2 billion 1:60,000
Kenya 37 45million 1:1,216,000
East Africa 5 65 140million 1:2,153,000
Comesa: 20 < 200 400 million 1:2,000,000
Africa: 54 < 500 1.1billion 1:2,200,000
Incentives
• Preferential public procurement
scheme
• Exempt on taxation
• Special Economic Zones (SEZs) and
Export Processing Zone provide even
lower taxes.
• Reduced regulatory fees.

14. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
• Regulatory Information Sharing
• Advancement of Local pharmaceutical manufacturing in
Kenya in line with Kenya’s Vision 2030
• Technology transfer for critical essential medicines,
vaccine, medical gases, medical devices and equipment
• Joint Ventures/Mergers and Acquisitions
• Establishment of Bioequivalence Centre
• Equipment Maintenance: Metrology, Calibration
• State-of-the-art Quality Control Laboratories
• Build Capacity for Pharmaceutical Industry
• Collaboration with Kenyan universities
14
Opportunities

15. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
Conclusion
15
Opportuni=es are like
sunrises.
If you wait too long, you
miss them.
William Arthur Ward

16. Republic of Kenya
Ministry of Health
Pharmacy and Poisons Board
Ensuring the provision of safe, quality and efficacious pharmaceu9cal products and services
THANK YOU – ASANTE SANA
Committed to
improvement
of health
Coopera=on
with
Partners
Build and
maintain
Partners
Provision of
safe, quality
and efficacious
Medical
Products and
Services
16
Contacts
Anthony Toroitich
Postal Address: P.O Box 27633-00506, Nairobi, Kenya
Tel(O) :+254 20 3562107, +254 720 208811
Email: toroitich@pharmacyboardkenya.org
Website: www.pharmacyboardkenya.org