Zambia Medicines Regulatory Authority - ZAMRA

03/09/2026

ZAMRA, NHRA SIGN MoU TO STRENGTHEN CLINICAL TRIAL REGULATION

In the spirit of harmonisation and reliance the Zambia Medicines Regulatory Authority (ZAMRA) and the National Health Research Authority (NHRA) have today, 3rd September 2026, signed a Memorandum of Understanding (MoU) to strengthen the regulation of clinical trials in Zambia.

The MoU addresses a key Institutional Development Plan (IDP) arising from a WHO-assisted Global Benchmarking assessment of both Authorities, particularly in the clinical trial regulatory function.

Speaking during the signing ceremony, ZAMRA Director-General, Mr Makomani Siyanga, said the partnership is aimed at supporting Zambia’s attainment of WHO Maturity Level 3 (ML3), a status signifying a stable, well-functioning and integrated national regulatory system for medicines and vaccines.

“Attainment of this status will open access for locally manufactured medicines to regional, continental and global markets, thereby bringing immense socio-economic benefits to Zambia,” Mr Siyanga said.

Meanwhile, NHRA Director and Chief Executive, Professor Victor Chalwe, reaffirmed the Authority’s commitment to ensuring that Zambia remains a competitive, credible and ethical destination for clinical research.

At the same ceremony, the NHRA Council Chairperson, Professor Hikabasa Halwiindi, said efficient and credible clinical trials generate the evidence needed to inform health policy, improve access to new medicines, and ultimately save lives. Zambia stands to benefit immensely.

Under the MoU, ZAMRA and NHRA will collaborate in clinical trial authorisation and monitoring, joint inspections, medicine safety monitoring, capacity building, information sharing and protection of trial participants.

Closing the meeting, ZAMRA Director Marketing Authorisation, Mr Lyoko Nyambe, urged both institutions to ensure that the commitments made translate into measurable improvements in clinical trial regulation and vigilance in Zambia.





#2026

28/08/2026

Together Against Fake and Substandard Medicines.

Protecting the health of Zambians requires teamwork.

This week, ZAMRA hosted its Quarterly Single Point of Contact (SPOC) Network Meeting, bringing together government agencies and partner institutions to strengthen the fight against illegal, substandard, and falsified medical products.

The meeting focused on improving information sharing, strengthening enforcement actions, and coordinating joint operations that help keep unsafe medicines out of our communities.

"As institutions, we are stronger when we work together," emphasized ZAMRA Director-General Mr. Makomani Siyanga, highlighting the importance of collaboration in protecting public health.

ZAMRA remains steadfast in its commitment to ensuring a safe, secure, and reliable supply of medicines for all Zambians.

27/08/2026

FROM TESTING TO TRUST: SADC VETERINARY ZAZIBONA PARTICIPANTS VISIT NDQCL

Participants in the SADC Veterinary ZaZiBoNa Governance Renewal and Strategic Planning Meeting have visited the National Drug Quality Control Laboratory (NDQCL) at the Zambia Medicines Regulatory Authority (ZAMRA), gaining first-hand insight into the critical role laboratory science plays in safeguarding both public and animal health.

The visit showcased NDQCL’s capacity to conduct quality testing and analysis of medicines and allied substances, supporting regulatory decisions and helping ensure that only products that meet required standards of quality, safety and efficacy are available on the Zambian market.

Beyond the laboratory walls, the visit highlighted an important pillar of the ZaZiBoNa initiative: building trust and confidence in regulatory systems across the SADC region.

By strengthening laboratory capabilities, sharing expertise and promoting the use of regulatory reliance, SADC Member States can reduce duplication, make better use of available resources and accelerate access to quality-assured veterinary medicines, while maintaining robust standards for animal and public health protection.

The NDQCL visit therefore served as a practical demonstration of how science, collaboration and regulatory cooperation can drive harmonisation and strengthen health systems across the region.

Collaboration Towards a Common Future for Safe Veterinary Medicinal Products.

27/08/2026

📢 ZAMRA and BOMRA Strengthen Partnership to Secure Medicine Supply Chains.

The Zambia Medicines Regulatory Authority (ZAMRA) and the Botswana Medicines Regulatory Authority (BOMRA) have reinforced their commitment to protecting public health through enhanced regional collaboration aimed at securing pharmaceutical supply chains.

As part of this initiative, a ZAMRA delegation visited Gaborone, Botswana, from 17 to 21 August 2026, where both regulatory authorities held engagements focused on the foĺlowing key areas of collaboration:

✅ Strengthening border enforcement through joint inspections and surveillance at points of entry.
✅ Advancing digital track-and-trace systems for medicines using GS1-compliant technologies.
✅ Enhancing market surveillance through coordinated post-marketing monitoring activities.
✅ Adopting rapid screening technologies to support the detection of counterfeit and substandard medicines.

This partnership represents a significant step towards a more secure, transparent, and resilient pharmaceutical supply chain in the region. By sharing intelligence, expertise, and innovative technologies, ZAMRA and BOMRA are working together to protect communities from unsafe medical products and ensure continued access to quality-assured medicines.

27/08/2026

ZAMBIA HOSTS SADC VETERINARY ZAZIBONA GOVERNANCE RENEWAL AND STRATEGIC PLANNING MEETING

Zambia is this week hosting the SADC Veterinary ZaZiBoNa Governance Renewal and Strategic Planning Meeting under the theme, “Towards a Common Future for Safe Veterinary Medicinal Products.”

Organised by the Veterinary Medicines Directorate of the United Kingdom (VMD-UK) in collaboration with the SADC Veterinary ZaZiBoNa Technical Working Group (TWG), the meeting has brought together Regulatory Authorities, Chief Veterinary Officers, SADC and Veterinary Association of Zambia (VAZ) representatives, as well as industry stakeholders to strengthen regional cooperation in the regulation of veterinary medicinal products.

Initially established to harmonise the assessment of human medicines and allied substances among Zambia, Zimbabwe, Botswana and Namibia, the ZaZiBoNa initiative was later expanded to include veterinary medical products, further strengthening regional efforts to protect animal health, food safety and livelihoods.

Speaking at the opening session on Monday 24th August 2026, Ministry of Fisheries and Livestock Deputy Director of Veterinary Services, Dr. Fusya Goma, highlighted the link between animal health, food safety, livelihoods and economic development, including Zambia’s target of exporting US$1 billion worth of beef by 2030.

Officially opening the meeting, ZAMRA Director-General, Mr. Makomani Siyanga, underscored the importance of regional collaboration, joint assessments, information and expertise sharing, and regulatory reliance to ensure efficient, consistent and effective regulation of veterinary medical products across the region.

Meanwhile, VMD-UK Team Lead, Dr. Osi Oyati, emphasised the need for coordinated regulatory systems to ensure that substandard and falsified veterinary medicines find “no weak gates” within the region.

During the first two days, Heads of Regulatory Authorities, SADC representatives and Chief Veterinary Officers shared experiences, renewed their commitment to the initiative and selected Botswana as the coordinating country.

The Technical Working Group meeting at the Radisson Blu Hotel in Lusaka, Zambia is, from the Wednesday to Friday developing a roadmap and establishing an effective governance structure to guide the future of SADC Veterinary ZaZiBoNa.

The initiative marks an important step towards stronger regional regulatory cooperation, safer veterinary medicines and healthier animals, contributing to food security, improved livelihoods and sustainable economic development across the SADC region.

26/08/2026

MEDICAL PRODUCT ALERT:

URGENT MEDICAL DEVICE RECALL, CLASS I TYPE B: SMARTBAG, FLEXPACK ACID CONCENTRATES (SEVERAL BATCHES) MANUFACTURED BY FRESENIUS MEDICAL CARE (PTY) LIMITED, SOUTH AFRICA.

The Authority wishes to notify all distributors, wholesalers, public and private hospital pharmacies, retailers and healthcare professionals on the recall of the above-mentioned product.

This followed the testing of prior-produced Smartbags which revealed the sporadic presence of neodymium, a lanthanide metal.

The manufacturer of the product has established that the metal leached from the magnetic drive in a defective pump that was used during the manufacturing process of the affected batches.

Click the link below for details:
https://www.zamra.co.zm/wp-content/uploads/2026/08/Publication_Public-Notice_Fresenius_Smartbag_24.08.2026.pdf

19/08/2026

URGENT PUBLIC ALERT:
RECALL OF ASSORTED MEDICINES

The Authority wishes to notify all healthcare professionals, health facilities,
pharmaceutical outlets, and members of the public of the urgent recall of assorted medicines due to quality defects.

click link below for details.
https://www.zamra.co.zm/wp-content/uploads/2026/08/Public-Notice_Assorted-Medicines_17.08.2026-2.pdf

18/08/2026

11/08/2026

ZAMRA HOLDS STAKEHOLDERS’ MEETING TO REVIEW GUIDELINES ON POST-MARKETING SURVEILLANCE

The Zambia Medicines Regulatory Authority (ZAMRA), through the Department of Licensing, Surveillance and Enforcement (DLSE), has held a two-day stakeholders’ meeting to review the Guidelines on Post-Marketing Surveillance (PMS) of Medicines and Allied Substances.

The meeting brought together key stakeholders from relevant Government institutions, regulatory bodies, the pharmaceutical industry, healthcare institutions, laboratories, academia and other partners involved in the regulation and monitoring of medicines and allied substances in Zambia.

The review was undertaken to ensure that the PMS Guidelines remain responsive to emerging public health and regulatory needs, incorporate lessons learnt from implementation, and align with current national regulatory requirements and relevant international best practices.

Key areas discussed included PMS planning and implementation, sampling methodologies, laboratory testing, management and reporting of quality defects, regulatory actions, product recalls and follow-up, as well as the roles and responsibilities of key stakeholders.

Stakeholders provided technical inputs and recommendations aimed at strengthening the implementation of post-marketing surveillance activities and improving coordination among institutions involved in monitoring the quality, safety and efficacy of medicines and allied substances on the Zambian market.

ZAMRA recognises that effective post-marketing surveillance requires collaboration among regulators, manufacturers, importers, distributors, healthcare professionals, laboratories, academia and other stakeholders.

We remain committed to strengthening regulatory oversight and surveillance systems to safeguard public health and ensure that medicines and allied substances available on the Zambian market meet the required standards of quality, safety and efficacy.

Recommendations from the meeting which took place from 30th to 31st July 2026 at the Mulungushi International Conference Centre in Lusaka, will be incorporated into the revised Guidelines, subject to the applicable regulatory review and approval processes.

10/08/2026

ZAMRA DG CALLS FOR COLLABORATION AMONG FUTURE HEALTH PROFESSIONALS

The Zambia Medicines Regulatory Authority (ZAMRA) Director-General, Mr. Makomani Siyanga, has called for stronger interprofessional collaboration among health professionals to improve patient care and strengthen healthcare delivery in Zambia.

Mr. Siyanga was speaking when he graced the Annual Blended Symposium organised by the University of Zambia School of Health Sciences Students Association (UNZASOHSSA) and the University of Zambia Biomedical Sciences Students Association (UNZABIOMEDSA), with support from affiliate student bodies including UNZAPHARMSA, UNZARADSA and UNZAPHYSIOSA.

Held under the theme: “Interprofessional Collaboration in Health Sciences: Leveraging Technology, Innovation and Entrepreneurship for Better Patient Care,” the symposium brought together students and professionals from various health disciplines, providing a platform for networking, mentorship, knowledge sharing and exploring opportunities in technology, innovation and entrepreneurship.

Mr. Siyanga observed that healthcare has for too long operated in professional silos, stressing that real, transformative patient care does not happen in isolation.

“True healthcare excellence relies on a robust health ecosystem that demands respect for every discipline, mutual understanding and active collaboration.” he emphasised.

Dean of Health Sciences at UNZA, Prof. Sody Munsaka, challenged students to maximise opportunities such as the symposium by learning from the experiences of professionals and applying the knowledge gained towards contributing to better healthcare in Zambia.

Other speakers included Mr. Samuel Banda, Administration Director for TATA Zambia and Malawi; Award-winning Biomedical Scientist and Founder/CEO of Biomed Connect Mr Frank Sandulu; and Ms. Maina Cheeba, Manager at ZAMBART Laboratories, who shared insights on entrepreneurship, innovation, research and public health.