Kenya Pharmaceutical Regulatory Overview and Opportunities

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



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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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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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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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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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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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



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



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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Regulation of Premise

•  Licenses for Retail, Wholesale and Manufacturers

•  Inspection, surveillance and enforcement

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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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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%



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.



•  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



Conclusion

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Opportuni=esarelikesunrises.Ifyouwaittoolong,youmissthem.WilliamArthurWard



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

Healthcare

Kenya Pharmaceutical Regulatory Overview and Opportunities