Rumbidzayi Zinyuke
Senior Health Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has committed to improving the speed, transparency and predictability of its regulatory services, setting targets for medicine registration and licensing as the country seeks to strengthen access to safe and quality healthcare products.
The authority says it intends to register medicines within 45 days and process certain licences within two days, as part of efforts to improve the ease of doing business while ensuring that medicines and medical devices available on the local market meet the required safety, efficacy and quality standards.
Speaking during the launch of the authority’s Client Service Charter in Harare on Monday, MCAZ public relations and communications manager, Davidson Kaiyo, said the Charter was designed to establish clear service standards for stakeholders and ensure that they received consistent and predictable services.
“The Client Service Charter is about the ease of doing business, ensuring that people of Zimbabwe have access to medicines that are safe, effective and of good quality in a timely manner. We want to set standards that apply equally to every stakeholder, so that there is predictability in our services and no perception that one stakeholder is being favoured over another,” he said.
The charter outlines the authority’s service commitments and timelines across key operational areas, including laboratory services, pharmacovigilance and clinical trials, information and communication technology, licensing and enforcement, and evaluation and registration.
Mr Kaiyo said the effectiveness of the charter would depend on its implementation by staff and stakeholders’ understanding of the services they could expect, rather than its mere publication.
“The value of the charter lies not merely in its publication, but in ensuring that its contents are understood by our stakeholders and consistently applied by the officers responsible for delivering these services. Every interaction with MCAZ must demonstrate professionalism, integrity, accountability and a commitment to continuous improvement,” he said.
The launch comes as Zimbabwe pursues broader economic and public service reforms under the Second National Development Strategy (NDS2), which seeks to accelerate economic growth, strengthen institutional efficiency and improve service delivery during the 2026–2030 period.
Within the health sector, efficient medicines regulation is important in ensuring that patients access quality medical products without unnecessary delays, while providing pharmaceutical companies and other regulated entities with a more transparent environment in which to operate.
The MCAZ has also demonstrated its capacity to expedite regulatory processes, with Mr Kaiyo citing the registration of lenacapavir, a long-acting HIV prevention medicine, in 23 days as an example of the authority’s ability to deliver within shorter timelines.
He said the authority intended to maintain such standards while safeguarding public health.
“As a leading regulator in Africa, we want to maintain the high standards for which we are recognised and continue delivering on our promises to the public. At the same time, we must ensure that the medicines and medical devices accessed by Zimbabweans are safe, effective and of good quality,” he said.
The authority’s service delivery commitments have also attracted interest from regional counterparts seeking to strengthen their own regulatory systems.
Uganda National Drug Authority public relations and communications officer Mr Kalungi Fred Kabuye said his organisation was in Zimbabwe to learn from MCAZ’s regulatory processes, particularly its digital systems, communication practices and turnaround times.
The MCAZ has attained World Health Organisation (WHO) Maturity Level 3 status, reflecting progress in strengthening its medicines regulatory system in line with international standards. The authority was assessed for Maturity Level 4 in April, the highest level of regulatory performance, and, if confirmed, Zimbabwe would become the first African country and only the fourth globally to attain the status.
Mr Kabuye said Uganda’s National Drug Authority was currently at Level 3, and expressed hope to identify practices that could help it advance further.
He said MCAZ’s digitalisation of services was one of the key areas that impressed the visiting delegation, as it made it easier for clients to access information and regulatory services without necessarily visiting the authority’s offices.
“We admire the way they have digitalised their systems across the authority, because this simplifies work for clients and makes services more accessible,” he said.
“When you compare the timelines for product registration and the documentation systems, there are areas where Zimbabwe is ahead of us, and we hope to learn from that experience.”
He said Uganda was still working to digitalise some of its critical regulatory services, with expensive and limited internet access in certain areas presenting additional challenges.
However, he noted that Uganda had established 10 regional offices to bring services closer to stakeholders, a model that could offer lessons for Zimbabwe as it seeks to improve accessibility.
Mr Kabuye said the exchange would help both regulators identify practical ways of improving their operations and service delivery.
“We have common challenges as African regulators, but there are also areas where we can learn from one another,” he said.
“As we spend these five days with MCAZ, we hope to pick up good practices that we can share with our colleagues back home and use to improve the services we provide to our clients.”
He said the exchange would also allow both regulators to learn from each other’s strengths, including approaches to enforcement and stakeholder engagement.
