Zambia’s Medicines Regulatory Authority (ZAMRA) and National Health Research Authority (NHRA) have signed a memorandum of understanding on the authorisation and monitoring of clinical trials, covering joint inspections of trial sites, medicine safety monitoring, information sharing and capacity building.
For sponsors and contract research organisations running or planning trials in Zambia, the operational change is that the two authorities intend to rely on each other’s work rather than duplicate it, which should shorten approval timelines and reduce parallel submissions. ZAMRA director-general Makomani Siyanga said the agreement will cut regulatory delays and harmonise requirements while strengthening protection of trial participants. No implementation date, revised timeline commitment or single submission route was announced, so sponsors should confirm current requirements with both bodies rather than assume the process has already changed.
Siyanga said the agreement addresses gaps identified during a WHO-assisted global benchmarking assessment, particularly in the regulation of clinical trials, and is part of Zambia’s effort to reach WHO Maturity Level 3. That status would support market access for locally manufactured medicines across regional, continental and global markets, he said. He called on researchers, academic institutions and pharmaceutical innovators to make use of the improved cooperation.
Professor Victor Chalwe, director and chief executive of NHRA, said the agreement is intended to make the regulatory process more predictable, transparent and efficient, and that Zambia should remain a competitive, credible and ethical destination for clinical research with protection of participants central to regulatory activity.
Source: Remarks by Makomani Siyanga, director-general, ZAMRA, and Professor Victor Chalwe, director and chief executive, NHRA, at a signing ceremony in Lusaka.
