Zimbabwe

Zimbabwe’s health research environment comprises universities, research institutions, clinical trial sites, and independent research organizations. Oversight of ethics review is mandated to Medical Research Council of Zimbabwe (MRCZ) at the national level, supported by Medicines Control Authority of Zimbabwe (MCAZ) and several Institutional Review Boards (IRBs) situated within academic and medical institutions.

While the regulatory architecture is established, the system continues to face challenges associated with outdated legislation, inconsistent operational standards, limited technical capacity, fragmented review processes, and inadequate digital infrastructure. These constraints limit the country’s ability to fully align with global ethical and regulatory benchmarks.

MCAZ| MRCZ

COUNTRY BACKGROUND

Zimbabwe is undertaking a national initiative to strengthen its health research ethics oversight system through the TRACE Project, implemented by the MRCZ in collaboration with the MCAZ. Supported by the Gates Foundation, the project aims to align the country’s ethics review and regulatory framework with internationally recognized standards for quality, transparency, and accountability.

Zimbabwe’s regulatory and ethics oversight framework has evolved steadily over the past four decades, anchored in two central bodies:

MCAZ, mandated to regulate medicines, clinical trials, and related products, including granting scientific and regulatory approval for clinical research.
MRCZ, mandated to provide national ethical oversight for all health research involving human participants.

MRCZ’s Role

Overseeing ethical compliance by:

Accrediting and supervising Institutional Review Boards (IRBs)
Reviewing and approving health-related research
Conducting monitoring visits and continuing review
Protecting the rights, safety, and well-being of human research participants

MCAZ’s Role

Regulation of clinical trials and medical products through:

Evaluation and approval of clinical trials
Inspection of research sites
Post-market surveillance
Ensuring safety, efficacy, and quality of medicines

KPIs and Milestones

Zimbabwe has officially achieved Maturity Level 4 (ML4) for its regulatory system under the WHO Global Benchmarking Tool (GBT) for medicines regulation, becoming the first country in Africa and only the fourth globally to reach this highest international standard.

What This ML4 Achievement Signifies

MCAZ operates an advanced, continuously improving regulatory system that consistently ensures the quality, safety, and efficacy of medical products.
Regulatory processes surpass standard benchmarks, joining an elite group of global regulatory leaders (including South Korea, Saudi Arabia, and Singapore).
Zimbabwe is strongly positioned as a primary gateway for pharmaceutical manufacturing and clinical trial excellence, serving as a key milestone toward designation as a WHO Listed Authority (WLA).

Strengthening Ethics Oversight Under the TRACE Project

This historic ML4 milestone provides a strong foundation for the complementary strengthening of ethics oversight under the TRACE Project, demonstrating Zimbabwe’s commitment to high standards of governance, accountability, and participant protection in biomedical research.

The continuous improvement activities undertaken include:

Baseline assessments of MRCZ and selected IRBs utilizing the WHO EBT.
Detailed reviews of relevant legislation, policies, and operational instruments to update Standard Operating Procedures (SOPs) and enhance transparency mechanisms.
Stakeholder consultations across Harare and Bulawayo to gather national insights on cross-border reforms and community engagement guidelines.
Independent expert assessments and site visits to IRBs and research institutions, supported by a decentralized "Training-of-Trainers" capacity-building model.
Development of a sustainable financing and resourcing model for MRCZ to stabilize core operations and reduce external reliance.
Advanced digital transformation processes for MCAZ and MRCZ, including a joint single-entry electronic review platform (e-CTR) to streamline coordination, integrate workflow systems, and eliminate duplicative submissions.

Why Change: Elevating Research Transparency in Zimbabwe

As a core partner of the TRACE initiative, Zimbabwe is moving beyond traditional oversight to establish a more visible and accountable research ecosystem. By modernizing its national approach to research ethics, the country is ensuring that its regulatory processes meet the highest international standards while remaining accessible to all stakeholders.

Zimbabwe: Modernizing Medical Research Framework Amid Digital Transformation

Zimbabwe is modernizing its medical research governance and accelerating digital ethics review systems after decades under outdated regulations. The Medical Research Council of Zimbabwe (MRCZ), established in 1974 under the Rhodesian Government Notice 225, has operated under a legal framework that has remained unchanged for over 50 years.