Medicines Control Authority of Zimbabwe

22/12/2025

The MCAZ joins His Excellency President Dr. E D Mnangagwa and the nation at large in celebrating Unity Day

16/12/2025

16/12/2025

The Medicines Control Authority of Zimbabwe (MCAZ) successfully convened a Consultative Stakeholders Meeting on the Production and Distribution of Locally Produced Medical Devices Regulations.

Stakeholders were allowed to review the draft regulations, share insights, and provide input aimed at strengthening the regulation of locally produced medical devices while supporting innovation and safeguarding public health.

MCAZ extends its appreciation to all stakeholders who participated and contributed to the consultative process.

12/12/2025

The Medicines Control Authority of Zimbabwe (MCAZ) welcomed a delegation from the Uganda National Drug Authority (NDA) led by Dr. Helen Byomire Ndagije, Director of Product Safety, for a two-week Vigilance Benchmarking visit. The MCAZ and Uganda NDA teams engaged in insightful knowledge exchange on Risk Management Plans (RMP) and PSUR/PBRER assessments, Good Pharmacovigilance Practices (GVP) inspections, current GBT requirements, and safety communication strategies. The visit also explored future collaboration opportunities between MCAZ and Uganda NDA to strengthen medicine and vaccine safety and regulatory systems across the region.

12/12/2025

📣IMPORTANT NOTICE: The Medicines Control Authority of Zimbabwe would like to inform its stakeholders that the Authority will be closed for its annual shutdown from Friday, 19th of December 2025, and will resume business on Monday, 5th of January 2026.

Physical examination (PE) and clearing of medicinal consignments at the Robert Gabriel Mugabe International Airport will be on selected days.

Other services will remain accessible via our online platforms, with a limited team available to provide support.

🚨Details:https://portal.mcaz.co.zw/wp-content/uploads/2025/12/CIRCULAR-34-OF-2025.pdf

11/12/2025

📢 MCAZ has launched the National Medicines Availability & Price Transparency Platform (MAP-TP), marking a significant milestone in the digital transformation of Zimbabwe’s public health and regulatory systems. The platform, also called Medicine Price Lookup, has been introduced to enhance transparency, strengthen patient protection, and provide citizens with accurate, non-promotional information on medicine availability and pricing nationwide.

The Authority is inviting licensed pharmacies to submit Expressions of Interest to join the pilot phase within 14 days. The pilot will allow MCAZ to test system functionality, validate data integrity, and ensure readiness ahead of national implementation.

🔗 Access the platform: lookup.mcaz.graccasoft.com

🚨 Details:https://portal.mcaz.co.zw/wp-content/uploads/2025/12/CIRCULAR-35-of-2025-PUBLICATION-IMPLEMENTATION-OF-THE-NATIONAL-MEDICINES-AVAILABILITY.pdf

10/12/2025

The Medicines Control Authority of Zimbabwe (MCAZ), in its capacity as the ZAZIBONA Implementing Agency, successfully coordinated the 3rd ZAZIBONA Quality Circle alongside fellow ZAZIBONA Member Agencies, including SAHPRA, BOMRA, ZAMRA, NMRC, among others. The Quality Circle was held from 8–9 December 2025.

This year’s session brought together 120 industry experts from across the SADC and EAC regions, demonstrating a shared commitment to regulatory harmonization and advancing pharmaceutical quality within the region.

Key technical topics covered included:
1. Technology transfer
2. Transport validation
3. HVAC system qualification
4. Microbiology testing of water
5. Common deficiencies in sterile manufacturing facilities
6. Common deficiencies in general oral solid dosage forms

MCAZ noted with appreciation the strong participation from Zimbabwean pharmaceutical manufacturers and technical professionals. This level of engagement reflects the country’s continued commitment to strengthening innovation, compliance with regulatory standards, and enhancement of technical capacity within the local pharmaceutical sector. Such collaboration aligns with national priorities and directly supports the National Development Strategy 2 (NDS2) objective of improving equitable access to quality-assured health products for all Zimbabweans.

Through these coordinated regional efforts, MCAZ and its ZAZIBONA counterparts continue to advance regulatory systems, promote capacity building within the pharmaceutical industry, and contribute to a more resilient and healthier SADC region.

08/12/2025

📢 The Medicines Control Authority of Zimbabwe (MCAZ) has published its Client Service Charter, now available on the Authority’s official website.

The Charter outlines MCAZ’s service standards, key commitments, turnaround times, and the rights and responsibilities of its clients. This publication reflects the Authority’s ongoing dedication to transparency, accountability, and high-quality regulatory service delivery.

👉 The Charter can be accessed onhttps://www.mcaz.co.zw/wp-content/uploads/2025/11/2025-client-service-charter.pdf

MCAZ remains committed to safeguarding public health through efficient, predictable, and customer-focused regulatory processes.

02/12/2025

Substandard and falsified (SF) medicines threaten millions of people worldwide.
Report to the MCAZ, any suspected SF products you may encounter. The Authority urges the public to access registered medicines from licenced persons and premises.

01/12/2025

Today, the Authority joins the global community in commemorating Day 2025.
MCAZ reaffirm its commitment to protecting public health by ensuring access to safe, effective, and good-quality medicines and medical devices.

Last month, the Authority approved and registered , an innovative long-acting medicine for pre-exposure prophylaxis (PrEP) to help prevent HIV-1 infection—supporting national and global efforts in the fight against HIV and AIDS.

Together, we can strengthen the response, save lives, and build a healthier future.

24/11/2025

🚨 ANNOUNCEMENT

🔊 The Medicines Control Authority of Zimbabwe (MCAZ) announces the expedited approval of , an innovative long-acting medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection.

The application, submitted by Gilead on the 29th of October 2025, underwent a rigorous evaluation and was finalised in twenty-three (23) days, demonstrating the Authority’s commitment to ensuring timely access to essential, life-saving health products.

The registration of marks a significant advancement in Zimbabwe’s HIV prevention strategy. By providing a long-acting alternative to daily oral , this product has the potential to improve adherence and expand prevention options for populations most vulnerable to HIV infection.

🔴 Details:https://portal.mcaz.co.zw/wp-content/uploads/2025/11/MEDIA-RELEASE-MCAZ-Registers-LENACAPAVIR_RvdDK-1ZAM.pdf

20/11/2025

MCAZ at the Zimbabwe Antimicrobial Resistance (AMR) Conference 2025
19–20 November | HICC

Quality-assured medicines are essential in protecting public health and preventing the spread of antimicrobial resistance (AMR).

At this year’s conference, MCAZ showcased its (handheld) portable field detection technologies that help rapidly identify substandard and falsified medicines in both human and veterinary sectors. These innovations strengthen surveillance beyond the laboratory and support timely regulatory action.

The Authority also had the opportunity to demonstrate the devices to the Minister of Ministry of Health and Child Care, highlighting the importance of technology and innovation in the fight against antimicrobial resistance.

Poor-quality medicines fuel AMR. Through strong surveillance and a One Health approach, MCAZ continues to protect people, animals, and the environment.