Medicines Control Authority of Zimbabwe

Medicines Control Authority of Zimbabwe MCAZ is responsible for protecting public and animal health by ensuring access to safe, effective, and good-quality medicines and medical devices

Medicines Control Authority of Zimbabwe is responsible for protecting public and animal health by ensuring that accessible medicines and allied substances and medical devices are safe, effective and of good quality through enforcement of adherence to standards by manufacturers and distributors. Medicines Control Authority of Zimbabwe (MCAZ) is a statutory body established by an act of Parliament

, The Medicines and Allied Substances Control Act (MASCA) [Chapter 15.03]. MCAZ is a successor of the Drugs Control Council (DCC) and the Zimbabwe Regional Drug Control Laboratory (ZRDCL). DCC was established by an Act of Parliament in 1969: Drugs and Allied Substances Control Act [Chapter 15.03] following which ZRDCL became operational in 1989. The mandate of MCAZ is to protect public health ensuring that medicines and medical devices on the market are safe, effective and of good quality.

Highlights of Day 5 at the Zimbabwe International Trade Fair Company ZITF Fruitful engagements with our stakeholders
25/04/2026

Highlights of Day 5 at the Zimbabwe International Trade Fair Company ZITF

Fruitful engagements with our stakeholders

24/04/2026
The MCAZ today engaged the media as the Director-General Richard Tendayi Rukwata announced the forthcoming World Health ...
24/04/2026

The MCAZ today engaged the media as the Director-General Richard Tendayi Rukwata announced the forthcoming World Health Organization (WHO) Formal Benchmarking Mission to Zimbabwe, scheduled for 27 April to 1 May 2026.

This high-level mission will reassess Zimbabwe’s medicines regulatory system using the WHO Global Benchmarking Tool, with the aim of determining the current maturity level, updating the Institutional Development Plan (IDP), and refining the national regulatory roadmap.

Building on Zimbabwe’s achievement of WHO Maturity Level 3 (ML3) in 2024, the mission represents a critical step towards attaining Maturity Level 4 (ML4), the highest level of regulatory performance, signifying a stable, well-functioning, and continuously improving system.

The DG emphasized that this mission is fully aligned with national priorities under NDS2 (Paragraphs 555 and 558) and Vision 2030, reinforcing the importance of strong regulatory systems in ensuring access to safe, effective, and quality-assured medical products.

The engagement with the media underscores MCAZ’s commitment to transparency, stakeholder engagement, and public accountability. The Authority calls upon all stakeholders to support this national effort.

This mission is not merely an assessment, but a strategic partnership aimed at strengthening Zimbabwe’s health systems and safeguarding public health.

Day 4 at the Zimbabwe International Trade Fair Company ZITF  continues to highlight the critical role of the MCAZ in saf...
23/04/2026

Day 4 at the Zimbabwe International Trade Fair Company ZITF continues to highlight the critical role of the MCAZ in safeguarding public health.

Visitors are continuing to interact with MCAZ experts, gaining insights into medicine safety, regulatory processes, and the Authority’s role as the home of Zimbabwe’s National Pharmacovigilance Centre.

MCAZ invites all ZITF attendees to visit its stand and learn more about how the Authority is protecting and promoting public health every day.

Day 3 at the Zimbabwe International Trade Fair Company ZITF has been both engaging and impactful for the MCAZ. The Autho...
22/04/2026

Day 3 at the Zimbabwe International Trade Fair Company ZITF has been both engaging and impactful for the MCAZ.

The Authority continues to interact with stakeholders, share critical information, and highlight its mandate in safeguarding public and animal health through the regulation of medicines and allied substances. Through these engagements, MCAZ is reinforcing its commitment to ensuring that all medicines in Zimbabwe meet the required standards of quality, safety, and efficacy.

Members of the public, stakeholders, and partners are encouraged to visit the MCAZ stand to learn more about its regulatory role, ongoing initiatives, and efforts towards strengthening medicines safety systems in Zimbabwe.

Visit the MCAZ stand and be part of the journey towards safer medicines for all.

Day 2 at the Zimbabwe International Trade Fair 2026 is in full swing!The MCAZ stand was privileged to host Chief Directo...
21/04/2026

Day 2 at the Zimbabwe International Trade Fair 2026 is in full swing!

The MCAZ stand was privileged to host Chief Director Hove from the Ministry of Health and Child Care, who visited to appreciate the Authority’s role and engage with officers.

📍 Don’t miss out! Come through to the MCAZ stand and:

✔ Learn about safe use of medicines
✔ Get expert guidance on any issue to do with medicines regulation including licensing of pharmacies, registration of medicines
✔ Discover how MCAZ protects you

MCAZ team is here for you, come and engage with us today!

ZITF 2026 Day 1 HighlightsThe MCAZ is now at ZITF 2026 in Hall 2A, showcasing innovations that drive “Connected Economie...
20/04/2026

ZITF 2026 Day 1 Highlights

The MCAZ is now at ZITF 2026 in Hall 2A, showcasing innovations that drive “Connected Economies, Competitive Industries.”

The Authority invite stakeholders to visit its stand for face to face interaction with MCAZ officers and learn more on the operations of the Authority and how it is working to protecting public and animal health, by making sure the medical products that are available in the Zimbabwean market are safe, effective and of good quality.


The Authority is thrilled to be exhibiting at the 2026 Zimbabwe International Trade Fair from 20-25 April. Visit us in H...
19/04/2026

The Authority is thrilled to be exhibiting at the 2026 Zimbabwe International Trade Fair from 20-25 April. Visit us in Hall 2 Stand Number 2A102 and learn more about medical products regulation in Zimbabwe, medicines safety monitoring persons and premises licensing and many more. MCAZ team is ready to answer any questions you may have.


The Authority joins the nation in celebrating 46th Independence Day  @46
18/04/2026

The Authority joins the nation in celebrating 46th Independence Day


@46

The MCAZ, recently hosted a pharmacovigilance (PV) benchmarking training in Harare, bringing together regulatory teams f...
15/04/2026

The MCAZ, recently hosted a pharmacovigilance (PV) benchmarking training in Harare, bringing together regulatory teams from the Medicines Control Agency (MCA) of The Gambia and the Namibia Medicines Regulatory Council (NMRC).

The training focused on practical, high-impact areas such as signal management, PSUR/PBRER assessment, GVP inspections, and regulatory reliance approaches, drawing on MCAZ’s established frameworks and experience. Beyond the technical sessions, the engagement created a valuable space for sharing experiences, aligning approaches, and strengthening collaboration across the region.

By hosting this initiative, MCAZ continues to support capacity building and the harmonisation of pharmacovigilance practices in Africa, helping partner institutions progress toward higher levels of regulatory maturity, including WHO Global Benchmarking Tool (GBT) Maturity Level 3.

MCAZ extends its appreciation to all participating teams and acknowledges the support of AUDA-NEPAD for facilitating this important exchange through the AU3S programme. Together, these efforts are contributing to stronger pharmacovigilance systems and promoting the safe and rational use of medicines across the continent.

The Authority was designated a Regional Centre of Regulatory Harmonisation under the African Medicines Regulatory Harmonisation (AMRH) Initiative of the African Union and the NEPAD Agency in 2014, offering training and services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia

🚨 Public Health Notice: Class II Recall of Azithromycin 500mg TabletsThe Medicines Control Authority of Zimbabwe wishes ...
14/04/2026

🚨 Public Health Notice: Class II Recall of Azithromycin 500mg Tablets

The Medicines Control Authority of Zimbabwe wishes to inform stakeholders of a voluntary Class II recall up to the retail level of:
➡️ Product: Azithromycin 500mg USP Tablets
➡️ Batch: 24050191
➡️ Manufacturer: Indoco Remedies Limited (India)

This recall follows an out-of-specification result in dissolution testing identified during stability studies. Such quality deviations may compromise treatment effectiveness and contribute to antimicrobial resistance.

🗒️ Details:https://portal.mcaz.co.zw/wp-content/uploads/2026/04/MEDIA-RELEASE-Azithromycin.pdf

Address

73 Dunmore Avenue Queensdale Harare, 106 Baines Avenues
Harare
0000

Opening Hours

Monday 08:00 - 16:30
Tuesday 08:00 - 16:30
Wednesday 08:00 - 16:30
Thursday 08:00 - 16:30
Friday 08:00 - 16:30

Telephone

+263772145191

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