zanzibar food drugs agency zfda

What zanzibar food drugs agency zfda does

Zanzibar Food and Drug Agency (ZFDA) is a semi-autonomous government regulatory body established in 2007 under the Zanzibar Food, Drugs and Cosmetics Act No. 2 of 2006 (amended by Act No. 3 of 2017), operating under the Ministry of Health Zanzibar. It serves as the sole statutory regulator for the safety, quality, and efficacy of food, medicines, cosmetics, medical devices, and in-vitro diagnostics circulating in the Zanzibar market, serving manufacturers, distributors, pharmacies, importers/exporters, and healthcare professionals across the archipelago.

ZFDA's core offerings fall into two categories. First, regulatory services delivered through four departments: Medicine and Cosmetics (product registration, pharmacovigilance, clinical trial evaluation, pharmacy profession regulation), Food Safety Control (inspection, enforcement, evaluation, and risk analysis), Laboratory Services (ISO/IEC 17025:2017-accredited testing across food chemistry, microbiology, medicine/cosmetics analysis, quality/technical advice, and medical devices testing), and Agency Services (administrative and institutional support). Second, digital e-services delivered via three web portals — the RIMS portal for premise/pharmacist registration, GMP inspections, product licensing, and import/export permits; the PV System for adverse drug reaction and vaccination event reporting; and the Clinical Trial System for trial approvals — plus an internal ERMS for enterprise operations.

ZFDA generates revenue through a transaction-based fee model published in a downloadable Fee and Charges document, charging for product registration (human and veterinary medicines, cosmetics, medical devices classes A–D, IVDs, biologics, antiseptics), premise and business permits (annual), GMP inspections tiered by geography, import/export permits (pay-as-you-go), and clinical trial permits and amendments. Fee income is supplemented by development assistance from WHO, World Bank, Global Fund, USAID, UK Aid, Bill & Melinda Gates Foundation, GIZ, and Swissmedic. The agency's ISO 9001:2015 certified QMS and participation in the East African Community Medicines Regulatory Harmonization (EAC-MRH) programme position it within a regional regulatory alignment framework alongside counterparts such as TMDA (Tanzania mainland), Rwanda FDA, Kenya PPB, and Uganda NDA.

Name

zanzibar food drugs agency zfda

Legal name

Zanzibar Food and Drug Agency

Website

https://zfda.go.tz

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Zanzibar Food and Drug Agency (ZFDA) is a semi-autonomous government regulator under Zanzibar's Ministry of Health, established in 2007, that registers and inspects food, medicines, cosmetics, medical devices, and diagnostics in Zanzibar through digital portals and physical offices on Unguja and Pemba islands.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Food Regulatory Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Official Development Assistance (ODA) Program Management (BPADAOAC)

Keywords

• Regulatory agency services
• Food safety regulation
• Medicines registration
• Pharmacovigilance reporting
• Medical device licensing

Headquarters

HQ city

Zanzibar (Unguja)

HQ country

Tanzania

HQ region

Africa

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Fees and Charges: Government regulatory agency generating revenue through fees for product registration, premise licensing, import/export permits, GMP inspections, business permits, and various service charges as defined in the Fee and Charges document.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

ZFDA is the statutory regulatory agency for food, medicines, cosmetics, medical devices and diagnostics in Zanzibar. It provides product registration, premise licensing, GMP inspections, import/export permit issuance, clinical trial approvals, pharmacovigilance reporting, and laboratory testing services to businesses and professionals operating in these regulated sectors. Services are delivered through digital e-services portals (RIMS, PV System, Clinical Trial System) and physical offices in Unguja and Pemba.

Product overview

ZFDA offers a portfolio of regulatory e-service portals and regulatory service departments. The core digital offerings include: the PV System for pharmacovigilance reporting, the Clinical Trial System for clinical trial applications, and the ZFDA RIMS portal for regulatory management including premises, pharmacist, and product registration, GMP inspection, and import/export permits. These are complemented by internal ERMS for enterprise operations. Beyond digital services, ZFDA provides regulatory services through its Department of Food Safety Control (inspection, enforcement, evaluation, risk analysis), Laboratory Services (testing under ISO/IEC 17025:2017), and Department of Medicine and Cosmetics (product registration, pharmacovigilance, clinical trial monitoring). The agency also publishes downloadable guidelines, SmPC documents, and regulatory frameworks through its website.

Differentiator

Problem solved

Functional benefit

Products and services

• ZFDA RIMS (Regulatory Information Management System) Comprehensive web portal for premise and pharmacist registration, GMP inspection applications, product license applications, and import/export permit applications. Used by pharmaceutical manufacturers, pharmacies, food businesses, and medical device companies seeking regulatory approval in Zanzibar.
• PV System (Pharmacovigilance Electronic Reporting System) Web-based system for reporting adverse drug reactions, product quality issues, and vaccination adverse events following immunization (AEFI). Used by healthcare professionals, manufacturers, and consumers in Zanzibar to report safety concerns.
• Clinical Trial System Online portal for submitting and managing clinical trial applications and approvals in Zanzibar. Used by pharmaceutical sponsors and research organizations conducting clinical trials in Zanzibar.
• Food Safety Control Services Inspection, enforcement, evaluation, registration, and risk analysis services for food safety. Includes Division of Food Inspection and Enforcement, Division of Food Evaluation and Registration, and Division of Food Risk Analysis and Foodborne Diseases. For food manufacturers, distributors, retailers, and food importers/exporters in Zanzibar.
• Laboratory Services Laboratory analysis of food, medicines, cosmetics, and testing of medical devices. Includes Food Chemistry Analysis, Microbiology Analysis, Medicine and Cosmetics Analysis, Quality and Technical Advice, and Medical Devices Testing divisions. Operates under ISO/IEC 17025:2017 quality standards. Used by ZFDA for enforcement decisions and offered to regulated businesses.
• Medicine and Cosmetics Regulatory Services Registration, importation/exportation regulation, post-marketing surveillance, pharmacovigilance, clinical trial evaluation, pharmacy profession regulation, and cosmetics control. Includes divisions for inspection, evaluation, medical devices, pharmacovigilance, and cosmetics. For pharmaceutical companies, cosmetics manufacturers, medical device companies, pharmacies, and healthcare product distributors in Zanzibar.

Quantifiable outcome

• Protection of public health through regulation of products meeting safety, quality and efficacy standards
• +2 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

13 partnerships are on record, tiered moderate and core.

• Hunan Medical Products AdministrationmoderateTechnology or Integration · 5 September 2025Chinese regulatory authority visit focused on strengthening cooperation, sharing regulatory experiences, and promoting collaboration in regulation of pharmaceuticals and cosmetics between China and Tanzania. Led by Deputy Director-General Qin Yongzhong.
• World Health Organization (WHO)coreStrategic or Co-development PartnerInternational health organization partner supporting ZFDA in regulatory capacity building, guidelines development, and public health protection initiatives.
• SwissmedicmoderateTechnology or IntegrationSwiss regulatory authority for therapeutic products providing technical assistance and regulatory expertise sharing.
• East African Community (EAC)coreStrategic or Co-development PartnerRegional intergovernmental organization through which ZFDA participates in EAC Medicines Regulatory Harmonization (EAC-MRH) programme for aligned regulatory requirements across East Africa.
• NEPADmoderateStrategic or Co-development PartnerAfrican Union development agency supporting continental health regulatory initiatives and capacity building.
• SADCmoderateStrategic or Co-development PartnerSouthern African Development Community regional bloc supporting harmonized regulatory approaches.
• TMEA (TradeMark East Africa)moderateStrategic or Co-development PartnerDonor-funded organization supporting growth of trade through improved regulations and standards implementation.
• Zanzibar Ministry of HealthcoreStrategic or Co-development PartnerParent ministry under which ZFDA operates as a semi-autonomous regulatory body.
• Tanzania Ministry of HealthmoderateStrategic or Co-development PartnerNational ministry coordinating health regulations across Tanzania including mainland and Zanzibar.
• Tanzania Medicines and Medical Devices Authority (TMDA)moderateTechnology or IntegrationNational regulatory authority counterpart on Tanzania mainland for medicines and medical devices regulation.
• Rwanda FDAmoderateTechnology or IntegrationRegional regulatory counterpart participating in EAC harmonization initiatives and joint regulatory activities.
• Kenya Pharmacy and Poisons BoardmoderateTechnology or IntegrationRegional regulatory counterpart in Kenya for pharmacy regulation and poisons control.
• Uganda National Drug Authority (NDA)moderateTechnology or IntegrationRegional regulatory counterpart in Uganda participating in EAC harmonization.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Tanzania Medicines and Medical Devices Authority (TMDA): The mainland Tanzania counterpart that regulates medicines, medical devices and diagnostics. Most directly comparable to ZFDA because it performs parallel functions (registration, GMP inspection, PV) just across the Zanzibar Strait and is named as a technology/integration partner.
• Uganda National Drug Authority (NDA): Uganda's national medicines regulator. Another EAC peer responsible for drug registration, GMP inspection and pharmacovigilance, partnered with ZFDA under EAC-MRH.
• Kenya Pharmacy and Poisons Board (PPB): Kenya's national regulator for pharmacy practice and drug registration. Regional EAC counterpart that performs product registration, premises licensing and PV functions analogous to ZFDA's.
• Rwanda Food and Drugs Authority (Rwanda FDA): Rwanda's national regulator covering food, medicines, cosmetics and medical devices. Direct EAC peer with comparable scope and EAC-MRH participation.

Broad incumbents

• Ghana Food and Drugs Authority (FDA Ghana): Established African national regulator with a similar combined food + drug + cosmetics + medical devices mandate. Comparable institutional design, though operating in a much larger and more industrialized market than Zanzibar.
• South African Health Products Regulatory Authority (SAHPRA): South Africa's national regulator for medicines, medical devices and related substances. A more mature African incumbent that ZFDA's partners engage with, useful as a regional benchmark.
• National Agency for Food and Drug Administration and Control (NAFDAC, Nigeria): Nigeria's national regulator covering food, drugs, cosmetics and medical devices. Comparable mandate and inspection/enforcement model, but at vastly larger scale.

Others

• Swissmedic: Swiss regulatory authority for therapeutic products. Listed as a technology/integration partner of ZFDA providing technical assistance and expertise sharing — a comparable mature regulator ZFDA engages with for capacity building.
• World Health Organization Prequalification Programme (WHO PQ): WHO programme that prequalifies medicines, vaccines and diagnostics for UN procurement. Comparable institutional function (QA + GMP assessment) and listed as a strategic WHO partner of ZFDA.

Emerging players

• Singapore Health Sciences Authority (HSA): Compact island-state regulator with strong digital e-services and laboratory infrastructure. Relevant benchmark for ZFDA's portal-driven, ISO-accredited operating model even though Singapore's market and scope are substantially larger.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/ZFDA_SMZ
• Facebookfacebook.com/Zanzibar-Food-and-Drug-Agency-ZFDA-127093987475409
• Instagraminstagram.com/zfda.go
• LinkedInlinkedin.com/company/zanzibar-food-drugs-agency-zfda

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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