National Health Research Authority

What National Health Research Authority does

National Health Research Authority (NHRA) is the statutory regulatory body for health research in the Republic of Zambia, established under the Health Research Act No. 2 of 2013 and headquartered in Lusaka. Its mandate is to provide a regulatory framework for the development, regulation, financing, and coordination of health research, ensuring consistent standards and ethically sound research conduct nationwide. NHRA serves individual health researchers, research institutions (including universities, hospitals, and research organizations), and Research Ethics Committees (RECs), all of which are legally required to register and obtain accreditation through the authority. Its core products include mandatory registration and accreditation services, study clearance, and specialized reviews (clinical trials, biobanks, material transfer agreements) — all administered through the third-party RHInnO Ethics platform (version 3.0, launched November 2023) and supplemented by an in-house e-learning portal.

The business model is a regulated fee-for-service structure denominated in Zambian Kwacha (ZMW), supplemented by government appropriations. NHRA charges statutory annual registration and accreditation fees (e.g., ZMW 1,020 domestic / ZMW 2,040 foreign for researcher registration; ZMW 2,010 domestic / ZMW 4,020 foreign for institution/REC registration), higher-value episodic fees for specialized reviews (special protocol review ZMW 4,000; biobank applications ZMW 50,000; expedited reviews up to ZMW 50,000), and per-participant training fees for Good Clinical/Laboratory Practice courses and the Data to Policy program. Revenue is also generated through annual events such as the Zambia Health Research Conference. Foreign applicants pay double the domestic rate, indicating a deliberate pricing posture toward international research sponsors.

Distribution is primarily through the self-serve RHInnO Ethics online platform, a dedicated headquarters office in Lusaka with departmental phone lines (Finance, Registration, Research Coordination, General), and a network of 25+ accredited partner RECs embedded in Zambian universities and institutions that act as local touchpoints. The organization is led by Prof. Victor Chalwe as Acting Director, with a reported headcount of approximately 11 employees. Strategic partnerships include the Ministry of Health Zambia, WHO Research, the Zambia National Public Health Institute (ZNPHI), and the Zambia Medicines Regulatory Authority (ZAMRA). NHRA operates exclusively within Zambia with no disclosed international commercial footprint.

Name

National Health Research Authority

Legal name

National Health Research Authority

Website

https://nhra.org.zm

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

National Health Research Authority is Zambia's statutory regulator for health research, established under the Health Research Act of 2013. It mandates registration and accreditation of health researchers, institutions, and Research Ethics Committees, delivering ethics reviews, study clearances, and training via the RHInnO Ethics platform.

Ownership category

akta.pro rank

Product category

Health Research Regulatory Services

NAICS

Administration of Public Health Programs (923120)

SIC

Services-Testing Laboratories (8734)

akta.pro industry

PRIMARYHLAJANAL

Economic Evaluation & Health Technology Assessment (Public Programs)

Healthcare & Life Sciences/Public Health, Government & Regulators/Health Program Evaluation & Surveillance

Keywords

• Health research regulation
• Research ethics oversight
• Clinical trial approval
• Researcher accreditation
• Research governance

Headquarters

HQ city

Lusaka

HQ country

Zambia

HQ region

Africa

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Others

Revenue model

1. Registration and Accreditation Fees: NHRA charges fees for registration of researchers (ZMW 1,020 domestic, ZMW 2,040 foreign), research institutions and RECs (ZMW 2,010 domestic, ZMW 4,020 foreign), accreditation fees, renewal fees, and special protocol review fees. These are statutory fees under the Health Research Act.
2. Training and Capacity Building Services: Fees for Good Clinical Practice/Good Laboratory Practice training (per participant pricing based on group size), Data to Policy course (ZMW 13,000), and expedited review services for high-risk studies.
3. Specialized Review Services: Fees for specialized reviews including clinical trials, vulnerable population studies, internationally funded studies, multi-site studies, Material Transfer Agreement applications (ZMW 5,010), and Biobank applications (ZMW 50,000).

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

The National Health Research Authority (NHRA) is the statutory regulatory body for health research in Zambia, providing registration, accreditation, study clearance, and ethics review services for health researchers, research institutions, and Research Ethics Committees. These services are administered through the RHInnO Ethics online platform and supported by an E-Learning system for capacity building. NHRA also issues special protocol reviews, Material Transfer Agreement clearances, biobank approvals, and training programs such as Good Clinical/Laboratory Practice and Data to Policy.

Product overview

The National Health Research Authority (NHRA) operates as a regulatory body for health research in Zambia, offering a platform of interconnected services centered on research governance. The core offerings include the RHInnO Ethics Platform for electronic ethics application management, along with registration and accreditation services for researchers, institutions, and ethics committees. Supporting modules include the NHRA E-Learning Course for researcher training, the Data to Policy Mentorship Program for evidence-based decision making, the Young Researchers Academy for early-career development, and the annual Zambia Health Research Conference for dissemination. The portfolio is unified by NHRA's regulatory mandate under the Health Research Act No. 2 of 2013, which encompasses research promotion, regulation, coordination, capacity building, and knowledge translation.

Differentiator

Problem solved

Functional benefit

Products and services

• Researcher Registration and Accreditation

Quantifiable outcome

• Mandatory registration and accreditation system ensures all health researchers and institutions comply with national standards.

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Four partnerships are on record, tiered core.

• World Health Organization (WHO) - Research DivisioncoreStrategic or Co-development PartnerWHO Research is listed as a key partner, indicating collaboration on international health research standards, guidelines, and capacity building initiatives in Zambia.
• Ministry of Health - ZambiacoreStrategic or Co-development PartnerStrategic partner for national health research policy coordination, regulatory alignment, and integration of health research into the national health agenda.
• Zambia National Public Health Institute (ZNPHI)coreStrategic or Co-development PartnerCollaboration on public health research, disease surveillance, and knowledge translation from research to public health policy.
• Zambia Medicines Regulatory Authority (ZAMRA)coreStrategic or Co-development PartnerRegulatory partnership for ensuring compliance with medicines and health product research regulations in Zambia.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Others

• African Research Integrity Network (ARIN): African network promoting research integrity and ethics across the continent. Comparable as a peer organization addressing research ethics standards and review capacity across African institutions.
• World Health Organization - Health Ethics & Governance: WHO's research ethics and governance unit, listed as a core NHRA strategic partner. Comparable as the global standard-setter whose guidelines shape NHRA's regulatory framework and review processes.
• Council on Health Research for Development (COHRED): International non-profit supporting low- and middle-income countries in strengthening health research systems. Comparable as a thematic peer focused on research governance and ethics capacity building in LMICs.
• Council for International Organizations of Medical Sciences (CIOMS): International body that develops ethical guidelines for health research, including the widely-used CIOMS International Ethical Guidelines. Comparable as a global standard-setter that informs NHRA's research ethics framework.
• EDCTP (European & Developing Countries Clinical Trials Partnership): International funder and capacity-building program supporting NHRA under a dedicated project ('EDCTP Support for NHRA'). Comparable as a strategic partner enabling African regulatory capacity, not a competitor but an adjacent ecosystem player.

Broad incumbents

• South African Health Products Regulatory Authority (SAHPRA): South Africa's national health products and research regulator. While broader in scope (covering medicines, medical devices, and clinical trials), it shares the function of approving and overseeing health research protocols at a national level in a neighboring SADC country.

Direct peers

• National Health Research Ethics Committee (NHREC) - Nigeria: Nigeria's national health research ethics regulator, performing the equivalent mandate of registering researchers, accrediting RECs, and clearing health research protocols at national scale. Directly comparable in function and statutory authority to NHRA Zambia.
• Uganda National Council for Science and Technology (UNCST): Uganda's national body for regulating science and technology research, including health research ethics review and approval. Directly comparable as a national-level African regulator of health and scientific research protocols.

Regional players

• Zambia Medicines Regulatory Authority (ZAMRA): Zambia's sister regulatory agency for medicines and health products, listed as an NHRA strategic partner. Comparable as a Zambian statutory health regulator operating under government oversight with similar compliance and licensing functions.
• Kenya Medical Research Institute (KEMRI): Kenya's leading health research institution, which also coordinates research ethics and scientific review in the East African context. Comparable as a major African national health research governance body.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UComL84RGn3NulKrgtvnUYhw
• Facebookfacebook.com/NationalHealthResearchAuthorityZambia
• LinkedInlinkedin.com/company/national-health-research-authority

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about National Health Research Authority