RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
Kenya Pharmaceutical Sector, Regulatory Overview and Opportunities
Anthony Toroitich Head, Trade Affairs, Pharmacy & Poisons Board
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18th August 2016 Hilton Hotel, Nairobi
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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.
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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
ManufacturePackaging&Labeling
Adver7sing Sale Use Disposal
Pre-marketPlacingonMarket
Post-MarketSurveillance
• Must comply with regulatory requirements to assure Quality, Safety and Efficacy
• Post Approval Commitments
Safety and Performance in
Market
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
Medical Products regulated by PPB
Borderline products
Blood & Blood products
Medical Devices and Dietary Supplements Biological products
Medicines (Human & Vet.)
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• Regulatory standards - Development
- Implementation - Monitoring
- Enforcement
• Pre-market evaluation & approval
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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
NoYes
Yes
Submission
Yes
Queries
Yes
No
Yes
No
Yes
PostMarke=ngAc=ons
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Reject
Appeal
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
Regulation of Premise
• Licenses for Retail, Wholesale and Manufacturers
• Inspection, surveillance and enforcement
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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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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RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
Medical Product Market OverviewYear
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%
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
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.
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
• 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
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
Conclusion
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Opportuni=esarelikesunrises.Ifyouwaittoolong,youmissthem.WilliamArthurWard
RepublicofKenyaMinistryofHealth
PharmacyandPoisonsBoardEnsuringtheprovisionofsafe,qualityandefficaciouspharmaceu9calproductsandservices
THANK YOU – ASANTE SANA
Committed to improvement
of health
Coopera=onwith
Partners
Build and maintain Partners
Provision of safe, quality
and efficacious Medical
Products and Services
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Contacts Anthony Toroitich Postal Address: P.O Box 27633-00506, Nairobi, Kenya Tel(O) :+254 20 3562107, +254 720 208811 Email: [email protected] Website: www.pharmacyboardkenya.org