Pharmacy and Poisons Board

What Pharmacy and Poisons Board does

The Pharmacy and Poisons Board (PPB) is the statutory regulatory authority of Kenya, operating under the Ministry of Health since its establishment in 1957, with mandate to regulate the pharmacy profession, medicines, vaccines, biologicals, blood products, medical devices, in vitro diagnostics, cosmetics, food supplements, and herbal and complementary medicines. PPB executes its regulatory functions — registration and marketing authorization, licensing, GMP inspections, clinical trials oversight, market surveillance, pharmacovigilance, and quality control — through an integrated digital platform ecosystem comprising the PRIMS portal (covering practice, products, GMP, and trade licensing), a separate Practice Licence Portal for professional renewals and CPD tracking, a Clinical Trials Portal, a Pharmacovigilance Portal, and a GMP/Products/Trade Portal, supplemented by regional offices for in-person services.

The organization's business model is fee-based, generating revenue from licensing and registration fees paid by pharmacies, distributors, manufacturers, and healthcare professionals, supplemented by inspection and compliance fees and permit fees for import/export and medical representative authorization. Customer segments span pharmaceutical manufacturers, retail and hospital pharmacies, wholesale distributors, individual pharmacy professionals, clinical trial sponsors, medical device companies, and the general public for adverse event reporting, with no publicly disclosed pricing or revenue figures.

PPB holds exclusive statutory authority within Kenya and maintains core strategic partnerships with the Ministry of Health Kenya, KEMRI, the Pharmaceutical Society of Kenya, the Kenya Pharmaceutical Association, USP, USAID, the EAC, NEPAD, IGAD, and NACOSTI to support regulatory science, capacity building, and regional harmonization.

Name

Pharmacy and Poisons Board

Legal name

Pharmacy and Poisons Board

Website

https://pharmacyboardkenya.org

Company type

Private

Founded year

1957

Operating status

Operating

Headcount range

51–100 employees

Short description

Pharmacy and Poisons Board is Kenya's statutory regulatory authority, established in 1957, that regulates pharmacy practice, medicines, medical devices, and health technologies through integrated digital portals for licensing, product registration, clinical trials, and pharmacovigilance.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulation

akta.pro primary industry

Controlled Substances & Pharmacy Regulation Authorities (HLAJACAI)

akta.pro secondary industries

Drug Regulators (Human Pharmaceuticals) (HLAJADAA), Healthcare Licensing, Accreditation & Credentialing Boards (HLAJACAC), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Medical Device Regulators (HLAJADAC), Controlled Substances & Narcotics Regulators (HLAJADAK)

Keywords

• Pharmaceutical regulation
• Medicine product licensing
• Pharmacy practice oversight
• Clinical trial approvals
• Pharmacovigilance services

Headquarters

HQ city

Nairobi

HQ country

Kenya

HQ region

Africa

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. Licensing and Registration Fees: Fees collected from licensing pharmacies, distributors, manufacturers, and healthcare professionals; product registration fees for medicines, vaccines, medical devices, cosmetics, and food supplements
2. Inspection and Compliance Fees: Fees from regulatory inspections of premises, GMP compliance verification, and Good Distribution Practice certification
3. Permit Fees: Fees for export/import permits for medicines and medical products, and medical representative licenses

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

The Pharmacy and Poisons Board is the national medicines regulatory authority of Kenya that licenses pharmacies and pharmacy professionals, registers medicines and health products, approves clinical trials, issues import/export permits, and conducts post-market pharmacovigilance to ensure the quality and safety of pharmaceutical products in the Kenyan market. It also regulates medical devices, diagnostics, blood products, narcotic substances, and health product advertising.

Product overview

The Pharmacy and Poisons Board (PPB) is Kenya's pharmaceutical regulatory authority operating a platform-based service model with multiple online portals and regulated product categories. The core offering consists of regulatory services including product registration, premises and practice licensing, clinical trials oversight, and pharmacovigilance. The online infrastructure comprises interconnected portals: PRIMS (the primary integrated system for practice licensing, product registration, GMP certification, and trade), the Practice Licence Portal for professional renewals and CPD, the Clinical Trials Portal for trial management, the Pharmacovigilance Portal for adverse event reporting, and the GMP/Products/Trade Portal for manufacturing and product management. PPB regulates a comprehensive portfolio of health products including Medicines, Vaccines and Biologicals, Blood & Blood Products, Medical Devices and IVDs, Cosmetics, Food Supplements, and Herbal and Complementary Medicines. Additionally, PPB provides guidance documents, safety communications, recalls, and maintains regional offices for direct service delivery.

Differentiator

Problem solved

Functional benefit

Products and services

• Marketing Authorisation (Product Registration) Statutory approval service that allows pharmaceutical manufacturers and importers to register and legally market regulated products in Kenya. Targets regulatory affairs teams at pharmaceutical companies.
• Pharmacy Premises Licence Licensing service for owners and operators of pharmacy premises across Kenya, ensuring facilities meet regulatory standards for operation.
• Pharmacy Practice Licence Professional licence service for pharmacists and pharmacy technicians, granting legal authority to practice in the pharmaceutical field in Kenya.
• Exports and Imports Permit Permit service that authorizes companies to import or export medicines, medical devices, and other regulated health products through Kenyan borders.
• Medical Representatives Authorisation Authorisation service licensing medical representatives employed by pharmaceutical companies to engage in product promotion activities within Kenya.
• Product Advertisements and Promotions Approval Approval service for advertisements and promotional content for pharmaceutical and health products, ensuring compliance with national advertising standards.
• Clinical Trials Approval Approval service for sponsors and investigators conducting clinical trials in Kenya, reviewing protocols for ethical and scientific compliance before trials can commence.
• Pharmacovigilance and Safety Reporting Post-market surveillance service for collection and evaluation of adverse drug reactions and safety reports from healthcare professionals, manufacturers, and the public.
• Training and Continuing Professional Development Educational service providing training programs and continuing professional development to pharmacy practitioners as part of regulatory licensing requirements.
• Recall and Market Withdrawal Service Regulatory service that coordinates the recall or withdrawal of pharmaceutical products identified as defective, unsafe, or non-compliant from the Kenyan market.
• Safety Alerts Service Communication service issuing public safety alerts regarding pharmaceutical products, adverse drug reactions, and emerging health risks to healthcare professionals and the public.

Segments7 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Kenya Medical Research Institute (KEMRI)coreStrategic or Co-development PartnerCollaborative relationship with Kenya's premier medical research institution for regulatory science, quality control, and research on medical products and health technologies in Kenya.
• Pharmaceutical Society of Kenya (PSK)coreStrategic or Co-development PartnerProfessional body partnership for pharmacy profession regulation, continuing professional development, and standards for pharmacy practice in Kenya.
• United States Pharmacopeia (USP)coreStrategic or Co-development PartnerInternational collaboration with USP for quality standards development, pharmacopeial reference standards, and regulatory capacity building.
• NEPAD (African Union Development Agency)minorStrategic or Co-development PartnerPan-African development agency partnership for harmonizing regulatory standards across African Union member states.
• Ministry of Health Kenya (MOH)coreStrategic or Co-development PartnerParent ministry relationship for health policy alignment, regulatory oversight coordination, and national health programs integration.
• East African Community (EAC)coreStrategic or Co-development PartnerRegional economic community partnership through the EAC Regional Medicines Regulatory Harmonization (RMRH) program for harmonizing pharmaceutical regulations across East African states.
• IGAD (Intergovernmental Authority on Development)minorStrategic or Co-development PartnerRegional intergovernmental organization partnership for regulatory harmonization in the Horn of Africa region.
• Kenya Pharmaceutical Association (KPA)coreStrategic or Co-development PartnerProfessional association partnership for industry standards, training, and pharmacy practice regulation.
• NACOSTI (National Commission for Science, Technology and Innovation)minorStrategic or Co-development PartnerNational regulatory body for science and technology research approvals and oversight of health-related innovations.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Rwanda Food and Drugs Authority (Rwanda FDA): Rwanda's central regulator for medicines, food, cosmetics, and medical devices. Comparable mandate and digital-first operating model to PPB, and an EAC harmonization partner.
• National Agency for Food and Drug Administration and Control (NAFDAC): Nigeria's national regulator for food, drugs, cosmetics, medical devices, and chemicals. Highly comparable to PPB in scope (multi-product oversight, licensing, registration) and in operating as the central pharma regulator for a major African market.
• Tanzania Medicines and Medical Devices Authority (TMDA): Tanzania's national medicines and medical devices regulator. A direct regional counterpart to PPB, collaborating through the EAC Regional Medicines Regulatory Harmonization (RMRH) program with overlapping regulatory functions.
• Ghana Food and Drugs Authority (FDA Ghana): Ghana's regulator for food, drugs, cosmetics, medical devices, and household chemicals. Similar scope and structure to PPB and a long-established African national regulatory authority.
• Uganda National Drug Authority (NDA): Uganda's national pharmaceutical regulator. Comparable to PPB across licensing, product registration, GMP inspections, and pharmacovigilance; partners through EAC harmonization efforts.
• South African Health Products Regulatory Authority (SAHPRA): South Africa's national medicines and health products regulator. Closely comparable to PPB in mandate (drug registration, licensing, inspections, pharmacovigilance), but operates in a larger and more industrialized pharmaceutical market.

Others

• WHO Prequalification Programme: WHO service that prequalifies medicines, vaccines, and diagnostics for UN procurement. Not a national regulator, but a directly relevant standards-setting counterpart that interacts with PPB on product eligibility for global health programs.

Broad incumbents

• U.S. Food and Drug Administration (FDA): The U.S. federal regulator for drugs, biologics, medical devices, food, and cosmetics. A global reference regulator whose frameworks and standards influence PPB's own requirements via USP and harmonization partnerships.
• Central Drugs Standard Control Organisation (CDSCO): India's national drug regulator under the Ministry of Health. Overlaps with PPB in drug registration and licensing functions, but operates at vastly larger scale as the regulator for one of the world's largest pharmaceutical industries.

Regional players

• Zambia Medicines Regulatory Authority (ZAMRA): Zambia's national pharmaceutical regulator. Comparable scope (medicines registration, premises licensing, inspections) but serves a different national market from PPB.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks4 records

Key highlights7 records

Customer concentration

• Xx.com/ppbkenya
• YouTubeyoutube.com/channel/UCD51Ul6KudMDl-r1Ju2ItVQ
• Facebookfacebook.com/pharmacyboardkenya
• LinkedInlinkedin.com/company/pharmacy-and-poisons-board

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Pharmacy and Poisons Board