The Work Package 3 Journey with LMHRA

The ECOWAS RegECs Project's Work Package 3 continues to make significant strides in enhancing regulatory capabilities across West Africa, specifically in Liberia and Senegal.

Background

In August 2024, the LMHRA underwent a comprehensive WHO Global Benchmarking Tool (GBT) assessment to evaluate their regulatory systems. Following this assessment, the Ghana Food and Drugs Authority (FDA) developed Institutional Development Plans (IDPs) targeting specific improvements needed to advance LMHRA's regulatory maturity levels.

A regulatory tour was subsequently organized in February 2025, bringing LMHRA personnel to Ghana FDA facilities to observe best practices in clinical trials oversight and regulatory operations. This exchange revealed that while progress has been made, several critical elements required by GBT standards remain outstanding, including:

• A dedicated Good Clinical Practice (GCP) guideline

• Critical SOPs for clinical trial activities

• Key Performance Indicators (KPIs) for monitoring regulatory performance

The Path Forward

To address these gaps and ensure the project achieves its intended outcomes, the initial roadmap has been extended beyond the original timeline. The revised plan provides a structured approach to finalizing essential documentation and implementing the IDPs fully.

1. Implementation of IDPs, March 3–December 2025: It is expected that the LMHRA ensure the continuous implementation of IDPs, including finalizing draft SOPs and guidelines during this period.

2. LMHRA Submission of CAPA Sheet, March 20, 2025: The LMHRA is expected to submit the Corrective and Preventive Action (CAPA) sheet to the FDA following the IDPs generated from the regulatory tour. This is a key step in addressing identified gaps. This will also allow the FDA to monitor and assess the progress of IDP implementation.

3. Review of LMHRA CAPA Sheet Submission, March 24–28, 2025: Review of the submitted CAPA sheet to assess compliance, ensure completeness, and identify any additional actions required.

4. Assisted Support to Develop Outstanding Documentation, April 2025: Support will be provided by the Ghana FDA to the LMHRA to develop any outstanding documentation in line with the WHO GBT requirements.

5. Verification of Implemented IDPs, July 2025: There will be a follow-up and verification of implemented IDPs to evaluate progress and effectiveness in addressing the gaps identified.

6. LMHRA Internal Review & FDA Continuous Verification of IDP Implementation, November 2025: It is expected that during this period the LMHRA will conduct an internal review of implemented IDPs to ensure that gaps identified have been adequately resolved. The FDA will also verify the implementation of the outstanding IDPs during this timepoint.

7. Closing Meeting & End of Project, December 2025: Final project review, closing meeting, and documentation of outcomes to mark the successful completion of the initiative. Strategies will be proposed to ensure continuous and sustainable implementation of the integrated IDPs. This will ensure LMHRA maintains compliance beyond the project timeframe and sustains improvements in its regulatory maturity levels.