Zambia Medicines Regulatory Authority (ZAMRA)

What Zambia Medicines Regulatory Authority (ZAMRA) does

Zambia Medicines Regulatory Authority (ZAMRA) is a statutory national medicines regulatory body established under the Medicines and Allied Substances Act No. 3 of 2013. It serves as the sole regulatory authority responsible for overseeing the manufacture, importation, storage, distribution, supply, sale, and use of medicines, medical devices, cosmetics, veterinary medicines, and allied substances in Zambia. ZAMRA serves pharmaceutical manufacturers and importers, wholesale and retail pharmacies, agro-vet shops, health shops, hospitals, and clinical trial sponsors, operating across five primary regulatory segments through both digital and physical channels.

ZAMRA's core operational technology is the Integrated Regulatory Information Management System (IRIMS), an online platform that digitises application submission, tracking, and permit approval for premise registration, marketing authorization, import/export permits, and clinical trial applications. The authority also operates a National Drug Quality Control Laboratory commissioned in June 2023, providing analytical testing for medicines, vaccines, medical devices, and cosmetics, and maintains a Pharmacovigilance System including the SafetyConnect (AfriVigilance Lite) platform under the African Union Smart Safety Surveillance Programme. The authority's services are accessible through a self-service e-portal, a call centre, and a network of eight physical offices spanning Zambia's provinces and key border crossings.

ZAMRA generates revenue through transaction-based regulatory fees (premise registration, marketing authorization, import/export permits, GMP certification, clinical trial applications) and laboratory services. Pricing is publicly disclosed on the ZAMRA website under separate fee schedules for human medicines, veterinary medicines, and allied substances. As a statutory government body, ZAMRA also receives government subvention, operates under parliamentary oversight, and is accountable to the Ministry of Health. The authority engages in international regulatory harmonisation through ZAZIBONA, AU-3S Programme, and bilateral reliance agreements, notably with the Egyptian Drug Authority.

Name

Zambia Medicines Regulatory Authority (ZAMRA)

Legal name

Zambia Medicines Regulatory Authority

Website

https://zamra.co.zm

Company type

Private

Founded year

2013

Operating status

Operating

Short description

ZAMRA is Zambia's statutory national medicines regulatory authority, regulating medicines, medical devices, cosmetics, and veterinary products through licensing, registration, inspections, and a digital IRIMS platform serving pharmaceutical companies, pharmacies, and healthcare facilities.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulation

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615), Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (926150)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

Keywords

• Pharmaceutical regulation
• Medicines licensing
• Pharmacovigilance services
• GMP certification
• Clinical trial oversight

Headquarters

HQ city

Lusaka

HQ country

Zambia

HQ region

Africa

Offices8 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain

Revenue model

1. Regulatory Fees and Licensing: ZAMRA generates revenue through fees for regulatory services including premise registration, marketing authorization, import/export permits, clinical trial applications, GMP inspections, and other licensing activities.
2. Laboratory Services: Scientific testing and analysis services provided to support regulatory decision-making for medicines, vaccines, medical devices, cosmetics, and other regulated products.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels7 records

Core offering

ZAMRA is the statutory national regulatory authority that licenses, registers, and oversees medicines, medical devices, cosmetics, veterinary medicines, and allied substances in Zambia. It issues marketing authorizations, GMP certifications, premise licenses, and import/export permits, conducts laboratory quality testing, and performs post-market pharmacovigilance and surveillance. These regulatory services are delivered through the IRIMS digital platform and physical offices across Zambia.

Product overview

ZAMRA is a statutory national medicines regulatory body that offers a comprehensive portfolio of regulatory services rather than a single product. The core offerings include Product Registration/Marketing Authorization, GMP Certification, Medical Devices and Allied Substances Regulation, Import/Export Permits, Premise Registration, Laboratory Services, Pharmacovigilance, Cosmetics Regulation, Veterinary Regulation, and Clinical Trial Regulation. These services are accessible through an E-Services Portal (IRIMS) for online submissions and tracking. ZAMRA also maintains public registers for marketing authorizations, premises, and clinical trials.

Differentiator

Problem solved

Functional benefit

Products and services

• Product Registration / Marketing Authorization
• Good Manufacturing Practice (GMP) Certification
• Medical Devices and Allied Substances Regulation
• Import and Export Permits
• Premise Registration
• Laboratory Services
• Pharmacovigilance / Monitoring the Safety of Medicines
• Cosmetics Regulation
• Veterinary Regulation
• Clinical Trial Regulation
• E-Services Portal (IRIMS)
• Single Point of Contact (SPOC) Network

Quantifiable outcome

• Processed over 15,000 applications through IRIMS system
• +1 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• AUDA-NEPAD (African Union Development Agency)coreStrategic or Co-development Partner · 25 August 2025AUDA-NEPAD, under the AU-3S Programme, convened a 3-day Vigilance Technology Onboarding Workshop in Lusaka for Wave 2 countries (DRC, Egypt, Mozambique, Rwanda, Senegal, Tanzania, and Uganda). With technical support from UK MHRA and Gates Foundation, AUDA-NEPAD brought together 15 pharmacovigilance and technology experts to accelerate Africa's safety surveillance systems. ZAMRA participates in the African Union Smart Safety Surveillance Programme.
• UK MHRA (UK Medicines and Healthcare products Regulatory Agency)coreTechnology or Integration · 25 August 2025Technical support partner providing expertise for the Vigilance Technology Onboarding Workshop under the AU-3S Programme. Supports Africa's safety surveillance systems development through training and technology transfer.
• Egyptian Drug Authority (EDA)coreStrategic or Co-development Partner · 5 June 2024MoU signed for collaborations in medicines, medical devices and cosmetics regulation. ZAMRA will rely on quality information summary from EDA in accordance with WHO guidelines for registration of Egyptian pharmaceutical products. Collaboration includes co-training programs, capacity building in technical, medical and therapeutic techniques.
• Clinton Health Access Initiative (CHAI)minorStrategic or Co-development PartnerCooperating partner collaborating with ZAMRA in developing Regulations and Guidelines on Traceability of Medicines and Allied Substances based on GS1 Global Standard.
• USAID Global Health Supply Chain Program – Procurement and Supply Management (GHSC-PSM)minorStrategic or Co-development PartnerCooperating partner collaborating with ZAMRA in developing Regulations and Guidelines on Traceability of Medicines and Allied Substances in the Zambian supply chain.
• UK Veterinary Medicines Directorate (VMD)coreTechnology or IntegrationSelected ZAMRA to participate in the pilot Veterinary global Benchmarking Tool (VgBT) project. VMD team conducted self-assessment training to measure ZAMRA's service delivery and efficiency in regulating Veterinary Medicinal Products. The tool is based on WHO global benchmarking tool adapted for veterinary products.
• World Health Organization (WHO)coreStrategic or Co-development PartnerWHO guidelines serve as the framework for regulatory reliance between ZAMRA and Egyptian Drug Authority. ZAMRA's benchmarking tool is based on WHO global benchmarking tool.
• Drug Enforcement Commission (DEC)coreStrategic or Co-development PartnerDEC and ZAMRA engage on effective control of codeine containing cough preparations. Collaboration aims to curb unauthorised importation and abuse of codeine-containing products in Zambia.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• South African Health Products Regulatory Authority (SAHPRA): National medicines regulatory authority for South Africa, the most mature NRA in the SADC region. Comparable as it performs the same statutory medicines regulation function across human/veterinary medicines, medical devices and clinical trials, but operates at significantly larger scale and WHO maturity level.
• Egyptian Drug Authority (EDA): Egypt's national medicines regulatory authority. ZAMRA has an active MoU with EDA (signed June 2024) for regulatory reliance, capacity building, and co-training - making them functional peers in cross-border reliance frameworks despite Egypt operating at significantly larger scale.
• National Agency for Food and Drug Administration and Control (NAFDAC) - Nigeria: Nigeria's federal regulatory agency covering medicines, foods, cosmetics, medical devices and chemicals. Comparable statutory mandate across human/veterinary medicines and cosmetics regulation, but operates at much larger scale across Africa's most populous country.
• UK Medicines and Healthcare products Regulatory Agency (MHRA): UK's medicines and medical devices regulator - a global reference agency. Functions as a technical support partner to ZAMRA under AUDA-NEPAD's AU-3S programme but also serves as a comparable peer in scope (human medicines, medical devices, pharmacovigilance) at significantly greater scale and maturity.

Direct peers

• Medicines Control Authority of Zimbabwe (MCAZ): Zimbabwe's national medicines regulatory authority with directly comparable mandate and scope. MCAZ visited ZAMRA in March 2024 specifically to learn from its IRIMS implementation, establishing them as the closest direct peer in regulatory digital maturity and SADC harmonization efforts.
• Tanzania Medicines and Medical Devices Authority (TMDA): Tanzania's national regulatory authority for medicines, medical devices and diagnostics. Comparable mandate covering human/veterinary medicines and medical devices, participation in ZAZIBONA harmonization, and similar digital modernization trajectory as ZAMRA.
• Ghana Food and Drugs Authority (FDA Ghana): Ghana's national regulatory authority for food, medicines, cosmetics, medical devices and household chemicals. Comparable West-African-style statutory NRA with similar product scope and participation in AU regulatory harmonization programmes.
• Kenya Pharmacy and Poisons Board (PPB): Kenya's national pharmacy and poisons regulator responsible for medicines registration, pharmacy practice regulation and product safety oversight. Functionally equivalent mandate across pharmaceutical licensing and medicine registration in an East African context.

Others

• AUDA-NEPAD African Medicines Regulatory Harmonisation (AMRH): African Union Development Agency programme coordinating continental regulatory harmonization including ZAZIBONA. Directly comparable to ZAMRA's regional harmonization work and serves as the convening framework under which ZAMRA operates with peer NRAs.
• World Health Organization Prequalification Programme: WHO programme that prequalifies medicines, vaccines and diagnostics for UN agency procurement. Comparable in its global benchmarking framework used by ZAMRA and serves as a standards-setting body that ZAMRA aligns its regulatory requirements against.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@ZambiaMedicinesRegulatoryAutho
• Facebookweb.facebook.com/zamra.zm/?_rdc=1&_rdr
• LinkedInzm.linkedin.com/company/zambia-medicines-regulatory-authority-zamra-

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Zambia Medicines Regulatory Authority (ZAMRA)