Background Past years have seen an increase in clinical trials being conducted in Zambia and other countries, which demand for the need to enhance the capacities of ethics committees and regulators to provide ethical oversight. In Zambia, there are multiple institutions tasked with the mandates to provide regulatory oversight over clinical trials, with each having specific legal mandates that include the National Health Research Authority, Zambia Medicines and Regulatory Authority and National Biosafety Authority. As such, clinical trial oversight has been highly segmented causing duplications of efforts, increased turnaround time, worsened by linear approach to submission of applications.

NHRA proposed harmonization of key processes amongst the key regulators within Zambia in the Zambia Health Research Systems Strengthening Project: Working Towards a Harmonized Regulatory Framework Project (ZAHRSSP) implemented by NHRA and supported by EDCTP.

Methods Desk review of existing Acts, guidelines and mandates was done during the implementation of the ZAHRSSP project.

Results a) Capacity building was conducted through provisions of training in research ethics, GCP, and protocol reviews. b) Transition from linear to parallel submission. In the implementation of ZAHRSSP project, the approach was changed into parallel submissions. c) Development of new clinical trial guidelines and regulations. The guidelines describe applications procedures for approvals, reviews, and approval of clinical trials. Key aspects of the harmonization process was realigning the submission forms amongst the key regulators. d) Memorandum of Understandings aimed at harmonizing key processes between NHRA and ZAMRA including conducting of joint clinical trial reviews and inspections.

Conclusion Steps have been taken for intra-collaboration towards a harmonized working environment for clinical trials oversight in Zambia with key regulators working together. However, need for sustaining the key collaborations aspects after the ZAHSSP project and ensure actualization of the key aspects of the guidelines, MOUs and regulations.