Zambia, Zimbabwe seal MoU to strengthen medicines regulation

Staff Reporter

The Medicines Control Authority of Zimbabwe (MCAZ) and the Zambia Medicines Regulatory Authority (ZAMRA) have signed a landmark Memorandum of Understanding (MoU) to boost cooperation in the regulation of medical products between the two countries.

The agreement will see the two regulators working together in key areas such as the detection of substandard and falsified medicines, development of track-and-trace systems, nanotechnology, biotechnology for medicines, vaccine production, and the manufacture of Active Pharmaceutical Ingredients (APIs), among other emerging scientific and regulatory fields.

MCAZ Director-General, Richard Rukwata, said the MoU was a game changer that would help the two countries deal decisively with the problem of fake and substandard medicines.

“This collaboration marks a significant milestone in regional regulatory convergence. By working together, ZAMRA and MCAZ will leverage each other’s expertise and resources to strengthen the fight against substandard and falsified medical products, and promote public health and safety in both nations,” he said.

Rukwata added that the agreement reflects the shared vision of both countries to ensure that citizens have access to safe, effective, and high-quality medicines.

“This is not just about cooperation for the sake of it. It is about making sure that when people in Zimbabwe or Zambia walk into a pharmacy or health facility, they can trust that the medicines they receive are safe and effective,” he said.

ZAMRA Director-General, Makomani Siyanga, said the MoU was also aimed at modernising regulatory systems in line with international best practices.

“This partnership underscores our shared commitment to ensuring that only safe, effective, and quality-assured medical products are accessible in our respective markets. It represents a proactive step toward harmonisation, efficiency, and innovation in our regulatory systems,” he said.

Siyanga said the agreement would also pave the way for increased investment by pharmaceutical industries across both countries.

“With harmonised systems, we are creating a friendlier environment for pharmaceutical manufacturers and investors.This is good for industry growth and for public health,” he said.

Under the MoU, the two regulatory bodies will cooperate on information sharing, capacity building, joint participation in international fora, and mutual recognition of Good Manufacturing Practice (GMP) inspections.

ZAMRA is a Government agency established under the Medicines and Allied Substances Act (No. 3) of 2013.

It is mandated to regulate and control medicines and allied substances to ensure consistent conformity to acceptable standards of quality, safety, and efficacy in their manufacture, importation, exportation, distribution, supply, sale, and use.

While the MCAZ is a statutory body established by an Act of Parliament, the Medicines and Allied Substances Control Act (MASCA) [Chapter 15.03], it succeeded the Drugs Control Council and the Zimbabwe Regional Drug Control Laboratory, which were responsible for overseeing medicine regulation in Zimbabwe since 1969.

Meanwhile the The MoU is expected to strengthen ties between Zimbabwe and Zambia in the pharmaceutical sector and enhance the protection of public health through more effective regulation of medical products.  The tracking of medicines from the manufacturers to the consumers will ensure there is no illegal street vending of expired medicines as well as rejects that have a potential to harm the public.