TMDA

What TMDA does

TMDA is the sole statutory regulatory authority for medicines, medical devices, diagnostics, and tobacco products in mainland Tanzania, operating under the Tanzania Medicines and Medical Devices Act. It succeeded the Tanzania Food and Drugs Authority (TFDA) and serves all pharmaceutical manufacturers, importers, distributors, clinical trial sponsors, and healthcare facilities operating in or exporting to Tanzania, as well as patients and the general public who rely on its safety and quality oversight.

The authority delivers regulatory services through an integrated digital platform anchored by the IMIS2 portal (imis2.tmda.go.tz), which handles product registration, premises licensing, GMP inspection applications, clinical trial submissions, and import/export permits. Public registries expose registered products, licensed premises, and approved clinical trials. Pharmacovigilance and product-quality reporting are operated through the Safety and Quality Reporting Tool (SQRT), accessible via web, USSD code (*152*00#), and a mobile application. Physical infrastructure comprises regional offices in Dodoma, Dar es Salaam, and Mwanza, with quality-control laboratories in Dar es Salaam and Mwanza, and integration with the e-Government Authority's ISO/IEC 27001:2022 certified infrastructure.

TMDA's operating funding derives from government budget allocations supplemented by regulatory fees, including product registration fees, GMP inspection charges, premises licensing fees, and import/export permit charges. Revenue is not publicly disclosed. The authority holds WHO Global Benchmarking Tool Maturity Level 3 status and ISO 9001:2015 certification, and participates in the EAC Medicines Regulatory Harmonization (EAC-MRP) and African Medicines Regulatory Harmonization (AMRH) initiatives. It is governed by a Medicines Advisory Board and led by Director General Dr. Adam Fimbo, headquartered in Dodoma.

Name

TMDA

Legal name

Tanzania Medicines and Medical Devices Authority

Website

https://tmda.go.tz

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

501–1,000 employees

Short description

TMDA is Tanzania's statutory regulatory authority for medicines, medical devices, diagnostics, and tobacco, providing registration, GMP inspection, pharmacovigilance, and clinical trial oversight via its IMIS2 portal and SQRT adverse-event reporting system.

Ownership category

akta.pro rank

Headquarters

HQ city

Dar Es Salaam

HQ country

Tanzania

HQ region

Africa

Offices13 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Distribution channels1 record

Marketing channels6 records

Core offering

TMDA is the statutory regulatory authority in Tanzania responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, and diagnostics. It delivers registration, licensing, inspection, clinical trials oversight, pharmacovigilance, import/export control, and laboratory testing services through the IMIS2 portal (imis2.tmda.go.tz), the Safety and Quality Reporting Tool (SQRT), and physical offices and laboratories across Tanzania.

Product overview

TMDA (Tanzania Medicines and Medical Devices Authority) is a regulatory body that does not offer a commercial product platform but provides regulatory services through a unified e-services portal architecture. The core offering consists of Online Medicines Registration, Online Medical Devices Registration, Import/Export Permit Application System, Online Premises Registration, Online GMP Application, and Online Clinical Trials Application System—all accessed through the imis2.tmda.go.tz portal. Supporting services include the Safety and Quality Reporting Tool (SQRT) at sqrt.tmda.go.tz for adverse event reporting, a Clinical Trial Registry System, and TMDA Laboratory Services across three locations. These interconnected systems form an integrated regulatory infrastructure for medicines and medical devices oversight in Tanzania.

Differentiator

Problem solved

Functional benefit

Brands

• SQRT App: Safety and Quality Reporting Tool for reporting adverse drug reactions, adverse events, and quality defects

Products and services

• Medicines Registration Service Electronic registration service for pharmaceutical manufacturers and local technical representatives seeking marketing authorization for medicinal products in Tanzania. Access is provided through the IMIS2 portal.
• Medical Devices Registration Service Registration and marketing authorization service for medical device manufacturers and IVD producers seeking market entry in Tanzania. Managed through the IMIS2 portal with public lists of registered and notified devices.
• Clinical Trials Application Service Electronic submission and review service for sponsors and researchers conducting clinical trials in Tanzania, including protocol review, approval workflow, and a public Clinical Trial Registry.
• Import and Export Permit Service Electronic permitting service for importers, exporters, and clinical trial sponsors handling medicines, medical devices, and investigational products at authorized Tanzanian ports of entry.
• Premises Registration and Licensing Service Licensing service for wholesale importers, distributors, and other regulated premises handling medicines and medical devices in Tanzania, including registered premises listings and GSDP/GDP compliance.
• GMP Inspection Service Good Manufacturing Practice (GMP) inspection application, scheduling, and reporting service for pharmaceutical and medical device manufacturers, including public GMP inspection reports.
• Safety and Quality Reporting Tool (SQRT) Pharmacovigilance reporting service for healthcare professionals, patients, and the public to submit adverse drug reactions, medical device adverse events, and product quality defects via web, USSD (*152*00#), and mobile app.
• TMDA Laboratory Testing Services Quality assurance laboratory testing service for medicines, medical devices, and complementary products, operated from TMDA laboratories in Dar es Salaam, Mwanza, and Dodoma.
• Registered Products Public Database Publicly searchable reference database listing medicines, medical devices, and in vitro diagnostics that have been registered with TMDA for use in Tanzania.

Segments6 records

Ideal customer profiles5 records

Technology focussed No

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, major and minor.

• World Health Organization (WHO)coreStrategic or Co-development PartnerTMDA participates in WHO collaborative procedures for medicines regulation, maintains WHO Maturity Level 3 status, and participates in WHO-supported harmonization initiatives. TMDA also participates in WHO World Health Assembly annually.
• African Medicines Agency (AMA)coreStrategic or Co-development PartnerTMDA participates in the African Medicines Agency harmonization initiative for continental regulatory cooperation.
• African Medicines Regulatory Harmonization (AMRH)coreStrategic or Co-development PartnerTMDA actively participates in the AMRH initiative aimed at harmonizing medicines regulation across Africa.
• East African Community (EAC)coreStrategic or Co-development PartnerTMDA implements East African Community Mutual Recognition Procedures (EAC-MRP) for harmonized regulatory approvals across EAC partner states.
• International Medical Device Regulators Forum (IMDRF)majorStrategic or Co-development PartnerTMDA participates in IMDRF as part of its international regulatory collaboration for medical devices.
• Global Harmonization Working Party (GHWP)majorStrategic or Co-development PartnerTMDA participates in GHWP activities for harmonization of medical device regulations globally.
• African Medical Devices Forum (AMDF)majorStrategic or Co-development PartnerTMDA participates in the African Medical Devices Forum for regional harmonization of medical device regulations.
• ANARME MozambiqueminorStrategic or Co-development PartnerTMDA facilitated a benchmarking training programme on regulatory activities for ANARME Mozambique from 4 to 18 May 2026 at its offices in Dodoma.
• e-Government AuthoritycoreTechnology or IntegrationThe TMDA website is designed, developed and maintained by e-Government Authority, Tanzania. TMDA also uses government mailing systems certified to ISO/IEC 27001:2022 and ISO 9001:2015.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• National Agency for Food and Drug Administration and Control (NAFDAC): Nigeria's national regulator for medicines, medical devices, and related products. Closest functional peer to TMDA: same mandate (registration, GMP inspection, pharmacovigilance), same customer base (local + multinational pharma), and same WHO Global Benchmarking Tool framework; only materially larger in absolute scale.
• Rwanda Food and Drugs Authority (Rwanda FDA): Rwanda's national regulator for food and medicines. Direct East African peer to TMDA performing comparable registration, inspection, and pharmacovigilance functions across a smaller market; participates in WHO ML benchmarking and AMRH initiatives.
• South African Health Products Regulatory Authority (SAHPRA): South Africa's national health products regulator. Comparable mandate covering medicines, medical devices, and IVDs with registration, GMP inspection, and pharmacovigilance functions; serves as a reference regulator in the SADC region analogous to TMDA's role in EAC.
• Zambia Medicines Regulatory Authority (ZAMRA): Zambia's national medicines regulator. Direct regional peer to TMDA with the same core mandate (medicine registration, GMP inspections, pharmacovigilance, import/export control); comparable scale and participates in the same continental harmonization initiatives.
• Pharmacy and Poisons Board (PPB) Kenya: Kenya's national medicines and poisons regulator. Direct peer to TMDA within the East African Community, sharing the EAC Mutual Recognition Procedure framework; performs registration, GMP inspections, pharmacovigilance, and pharmacy premises licensing with comparable scope.

Broad incumbents

• Pharmaceuticals and Medical Devices Agency (PMDA Japan): Japan's national medicines and medical devices regulator. Comparable medicines + medical devices mandate with registration, GMP, and post-market safety functions; IMDRF member alongside TMDA and a globally influential reference regulator for Asian and African NRA capacity-building programs.
• Therapeutic Goods Administration (TGA Australia): Australia's national regulator for medicines, medical devices, and IVDs. Directly comparable mandate to TMDA across product categories with mature registration, GMP inspection, and post-market surveillance frameworks; WHO ML3-equivalent and IMDRF founding member.
• Medicines and Healthcare products Regulatory Agency (MHRA): UK's national medicines and medical devices regulator. Overlaps TMDA's mandate on medicines and devices with mature registration, inspection, and pharmacovigilance functions; WHO ML3-equivalent regulator used as a reference model for emerging NRAs including TMDA.
• European Medicines Agency (EMA): EU-level medicines regulator. Performs centralized marketing authorization analogous to TMDA's national registration function but at multi-country scale; benchmark regulator for scientific assessment standards and pharmacovigilance systems.
• US Food and Drug Administration (US FDA): US national regulator for medicines, medical devices, food, and cosmetics. Overlaps TMDA's medicines and medical devices mandate but at vastly greater scale and with global benchmark influence; relevant as the reference standard that TMDA's systems are benchmarked against under WHO ML.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/tmda_tanzania
• YouTubeyoutube.com/channel/UCbcIveqGdf18mVyUqzAoL9Q

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TMDA