National Drug Authority

What National Drug Authority does

National Drug Authority (NDA) is the statutory regulatory body of Uganda, established under the National Drug Policy and Authority (NDPA) Act and operating under the supervision of the Ministry of Health. Its mandate covers the manufacture, importation, distribution, and use of human and veterinary drugs as well as medical devices. Headquartered at NDA Tower in Kampala, the authority serves pharmaceutical manufacturers, importers, retail pharmacies, drug shops, veterinary pharmacies, clinical research organizations, medical device companies, healthcare providers, and the veterinary/livestock sector.

NDA's core technology platform is the Integrated Regulatory Information Management System (IRIMS), an online portal handling product registration, drug outlet licensing, clinical trials registration, drug recalls reporting (RCALLS), and promotional material approvals. Its National Drug Quality Control Laboratory (NDQCL) holds ISO/IEC 17025:2017 accreditation for pharmaceutical quality testing. The authority also maintains an ADR/AEFI Reporting System integrated with WHO's VigiFlow for international pharmacovigilance, alongside public registries covering the Drug Register, Licensed Outlets, Clinical Trials, and 300+ GMP-compliant manufacturing facilities internationally.

As a government regulatory authority, NDA does not generate commercial revenue and is funded through government allocations and regulatory fees. Its go-to-market is statutory enforcement: licensing drug outlets, certifying manufacturers, conducting multi-district enforcement sweeps that close unlicensed pharmacies and impound counterfeit medicines, and approving new therapeutics. The authority maintains international partnerships with WHO, the East African Community Medicines Regulatory Harmonization (EAC-MRH) Programme, the National Association of Boards of Pharmacy (NABP), and Kenya's Pharmacy and Poisons Board, and is ISO 9001:2015 certified under SGS.

Name

National Drug Authority

Legal name

National Drug Authority

Website

https://nda.or.ug

Company type

Private

Founded year

1993

Operating status

Operating

Headcount range

11–50 employees

Short description

National Drug Authority is Uganda's statutory regulator controlling the manufacture, importation, distribution, and use of human and veterinary drugs and medical devices. It serves pharmaceutical manufacturers, importers, pharmacies, and clinical research organizations through its IRIMS portal and ISO-accredited laboratory.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulation

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615), Medical and Diagnostic Laboratories (62151)

SIC

Services-Testing Laboratories (8734), Services-Medical Laboratories (8071)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Veterinary Regulatory Authorities (Licensing, Compliance & Enforcement) (HLAMAJAC), Medical Device Regulators (HLAJADAC), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Controlled Substances & Narcotics Regulators (HLAJADAK)

Keywords

• Pharmaceutical regulation
• Drug registration services
• Pharmacovigilance monitoring
• Medicine licensing
• Quality control testing

Headquarters

HQ city

Kampala

HQ country

Uganda

HQ region

Africa

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Distribution channels1 record

Marketing channels6 records

Core offering

National Drug Authority regulates the safety, quality, and efficacy of human and veterinary drugs, as well as medical devices, in Uganda. It provides digital regulatory services via its IRIMS online portal for product registration, drug outlet licensing, and clinical trial oversight. It operates an ISO/IEC 17025:2017 accredited quality control laboratory and runs a national pharmacovigilance system integrated with WHO for adverse drug reaction reporting.

Product overview

National Drug Authority operates as Uganda's pharmaceutical regulatory body offering a suite of digital services through its Integrated Regulatory Management Information System (IRIMS). The core product portfolio includes regulatory submission portals (IRIMS Client), public registries (Drug Register, Licensed Outlets, Clinical Trials, GMP Facilities), pharmacovigilance tools (ADR/AEFI Reporting integrated with WHO VigiFlow), and the accredited National Drug Quality Control Laboratory (NDQCL). NDA also provides medical devices regulation under Statutory Instrument No. 77, drug recalls management (RCALLS), and an e-resources database. These products collectively enable regulatory compliance verification, adverse event reporting, quality assurance, and market surveillance for human medicines, veterinary drugs, and medical devices across Uganda.

Differentiator

Problem solved

Functional benefit

Products and services

• IRIMS Online Portal (Integrated Regulatory Management Information System) Online regulatory portal enabling pharmaceutical companies, importers, and retailers to submit applications for drug registration, drug outlet licensing, clinical trial registrations, drug recall reporting, and promotional material approvals. Used by industry stakeholders to comply with NDA regulatory requirements.
• Drug Register Public registry of all drugs registered and approved for sale in Uganda, providing verified product information to healthcare providers, patients, and industry stakeholders.
• RCALLS (Regulatory Compliance and Lookback System) Drug recalls management system enabling tracking and management of pharmaceutical product recalls in Uganda, providing a public database of recalled products.
• ADR/AEFI Reporting System Pharmacovigilance system for healthcare providers, patients, and industry to report adverse drug reactions (ADRs) and adverse events following immunization (AEFIs). Integrated with WHO-UMC VigiFlow international reporting platform for global pharmacovigilance participation.
• National Drug Quality Control Laboratory (NDQCL) Accredited laboratory providing quality testing and analysis services for pharmaceutical products, holding ISO/IEC 17025:2017 accreditation. Supports regulatory testing for NDA and provides analytical services to industry and government agencies.
• Licensed Outlets Registry Public database of all licensed pharmaceutical outlets including pharmacies, drug shops, and veterinary pharmacies operating legally in Uganda, providing transparency for consumers and regulatory oversight.
• Clinical Trials Register Public registry of approved and ongoing clinical trials conducted in Uganda under NDA oversight, providing transparency for researchers, sponsors, and the public.
• GMP Compliant Facilities Database Database of pharmaceutical manufacturers that have received Good Manufacturing Practice (GMP) certification from NDA, including facility details and valid certification dates. Lists over 300 GMP-compliant facilities internationally.
• Medical Devices Regulatory Services Comprehensive regulatory services for medical devices including registration, licensing (manufacturer, wholesale, supply), and adverse event reporting under Statutory Instrument No. 77. Used by medical device manufacturers, importers, and suppliers.

Quantifiable outcome

• Approval of Lenacapavir (Sunlenca) twice-yearly PrEP from Gilead for HIV prevention
• +1 more outcomes

Segments6 records

Ideal customer profiles6 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Pharmacy and Poisons Board (PPB) of KenyacoreStrategic or Co-development Partner · 1 July 2025NDA collaborated with PPB Kenya under Operation African Star partnership with NABP to host a 3-day training on Pharmaceutical Traceability Pilot Program. The training strengthened regulated supply chains and targeted NDA inspectors, other stakeholders, and government agencies.
• National Association of Boards of Pharmacy (NABP)coreStrategic or Co-development PartnerInternational partner in Operation African Star providing expertise and support for pharmaceutical traceability training programs across regulatory authorities in Africa.
• Uganda Registration Services Bureau (URSB)coreStrategic or Co-development PartnerURSB delivered a presentation at NDA's Research Roundtable Discussion on protecting innovation in traditional and complementary medicines using patent databases. This partnership is preparing NDA staff for the launch of Technology and Innovation Support Centre (TISC).
• World Health Organization (WHO)coreStrategic or Co-development PartnerNDA participates in WHO pharmacovigilance programs, reporting adverse drug reactions through WHO-UMC international system. Related links section includes WHO reporting platform integration.
• East African Community Medicines Regulatory Harmonization (EAC-MRH) ProgrammecoreStrategic or Co-development PartnerNDA participates in regional regulatory harmonization efforts through EAC-MRH Programme for alignment of medicines regulatory standards across East African partner states.
• Ministry of Health (Uganda)coreOthersRelated government ministry with collaborative relationship in public health regulation and drug policy.
• Ministry of Agriculture, Animal Industries & Fisheries (Uganda)coreOthersCollaborative partner for veterinary drug regulation, tick and tick-borne disease control, and agricultural pharmaceutical oversight.
• Makerere University College of Veterinary MedicineminorStrategic or Co-development PartnerAcademic partner in acaricide resistance research and evidence-based prescription models for tick control in Uganda.
• National Livestock Resources Research Institute (NaLIRRI)minorStrategic or Co-development PartnerResearch partner coordinating pre-registration field trials for acaricide efficacy testing in Uganda.

Scale indicators5 records

Recent moves5 records

Expansion highlights6 records

Broad incumbents

• World Health Organization (WHO) Prequalification Programme: WHO's global service for prequalifying medicines, vaccines, and diagnostics for procurement agencies. NDA's NDQCL accreditation and pharmacovigilance integration with WHO-UMC are designed in alignment with WHO Prequalification standards.
• European Medicines Agency (EMA): The EU's central medicines regulator. EMA's GMP, pharmacovigilance, and centralized assessment procedures serve as reference standards that shape NDA's expectations for imported European GMP-certified facilities.
• US Food and Drug Administration (FDA): The US federal regulator covering drugs, biologics, medical devices, food, and cosmetics. NDA aligns many processes to FDA-style frameworks; FDA's standards and inspections effectively set the upstream requirements NDA must verify at foreign manufacturing sites.

Direct peers

• Food and Drugs Authority Ghana (FDA Ghana): Ghana's national regulator for food, drugs, cosmetics, medical devices, and household chemicals. Directly comparable scope and African regulatory context, with similar WHO Prequalification-aligned processes.
• Tanzania Medicines and Medical Devices Authority (TMDA): Tanzania's national regulator for medicines and medical devices. Closely comparable scope and EAC regional harmonization partner, making it a like-for-like peer for NDA's product registration, GMP inspection, and pharmacovigilance functions.
• National Agency for Food and Drug Administration and Control (NAFDAC): Nigeria's federal regulator for foods, drugs, cosmetics, medical devices, and chemicals. Comparable African national regulator with similar functions in product registration, GMP inspection, and counterfeit drug enforcement.
• South African Health Products Regulatory Authority (SAHPRA): South Africa's national health products regulator covering medicines, medical devices, and clinical trials. The most mature African national regulator; directly comparable mandate but at substantially greater scale and resource depth than NDA.
• Rwanda Food and Drugs Authority (Rwanda FDA): Rwanda's national medicines and food regulator and EAC regional peer. Comparable mandate in a smaller market, making it useful for benchmarking on regulatory efficiency and digital adoption.
• Pharmacy and Poisons Board (PPB) Kenya: Kenya's national drug regulatory authority, counterpart to NDA Uganda within the EAC-MRH framework. Directly comparable mandate covering human medicines, veterinary drugs, and pharmacy licensing, and a confirmed joint partner on Operation African Star traceability training.

Others

• National Association of Boards of Pharmacy (NABP): US-based international umbrella of pharmacy regulators. NABP's direct partnership with NDA through Operation African Star pharmaceutical traceability training makes it a key ecosystem enabler rather than a competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/UNDAuthority
• Facebookfacebook.com/UNDAuthority
• LinkedInlinkedin.com/company/national-food-and-drug-authority
• Instagraminstagram.com/ndauganda

Compliance2 records

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 National Drug Authority