Comprehensive Announcement: Liberia’s First Clinical Trial Regulation Launched at Stakeholder Meeting
The Liberian Medicines and Health Products Regulatory Agency (LMHRA) officially launched its first clinical trials regulation at a meeting with the minister of health and stakeholders involved in clinical trials in Liberia. The document was developed by LMHRA through the support of the GHPP-VaccTrain project team.
The launch took place in Monrovia on July 29th, 2022. The meeting´s aim was to make all relevant stakeholders as well as the public aware of the new regulatory requirements for clinical trials. The new regulation is intended to ensure that all clinical trials conducted in Liberia follow Good Clinical Practice and that the rights and safety of study participants are safeguarded.
Regulation is legal foundation for clinical trials oversight
The Clinical Trials Regulation is a core regulatory document for clinical trials. It lays the foundation for the conduct and regulatory oversight of clinical trials in Liberia (e.g., conditions for granting, renewing, suspending, and revoking such approvals). It is also a prerequisite for LMHRA to achieve a higher level of maturity according to the WHO Global Benchmarking Tool. The Liberian regulatory authority developed the Clinical Trials Regulation in close collaboration with the GHPP VaccTrain team. Following the approval of the regulation by the LMHRA Board of Directors in February 2022 (see report), the path was now clear to officially launch and publicize it.
Launch brings all stakeholders together
The launch took place during a high-level meeting opened and chaired by the Minister of Health of Liberia. The participation of the Minister of Health indicates the high importance that clinical trials have for the public health of Liberia. The meeting brought together about 60 stakeholders involved in clinical trials in Liberia such as but not limited to the National Ethics Committee, clinical trials investigators, sponsors, clinical research organisations, research institutes, medical schools, civil society organizations.
Kick-off for implementation
During the meeting, LMHRA presented the regulation in detail and answered questions from the audience. LMHRA Managing Director Keturah Smith-Chineh stressed that before a vaccine or medicine is approved for the treatment of disease, its efficacy, safety and quality must be demonstrated within clinical trials. She also expressed her confidence in the new clinical trial regulation to help curb the risks of inadequate clinical data, undocumented side effects or trials that do not follow the scientific standard. As reported by the news portal Front Page Africa, the Liberian Minister of Health Dr. Wilhelmina Jallah said in her concluding remarks, that the regulation will ensure that scientific research on medicines is conducted properly. She expressed optimism that the regulation will ensure the safety of those in the country. (Front Page Africa, 03. August 2022, online)
In a comment, Dr Juwe D. Kercula, head of the Clinical Trials Division at LMHRA who has been working on capacity building with the VaccTrain team since 2018, says: “We are very pleased with the interest of all the key stakeholders and their active participation. It was a very successful launch for CT Regulation and it will greatly facilitate the rapid implementation of the new requirements.”
From the VaccTrain team, Dr. Olga Rassokhina, Dr. Ulysse Ateba Ngoa and Dr. Solomon Owusu Sekyere attended the event virtually and presented the VaccTrain project with its goals and outcomes. In a remark following his presentation on behalf of the VaccTrain, Dr Owusu Sekyere highlighted: “The personal participation of the Minister of Health and the leadership of all relevant stakeholders who conduct, apply for, or review clinical trials sends a strong signal of how Liberia considers clear regulatory requirements and processes as central, and of dire importance, to the conduct of clinical trials in the country. Everyone is still very much mindful of the Ebola crisis, where the lack of precisely these transparent regulatory guidance documents and processes paralyzed rapid approval of clinical trials of urgently needed vaccines.”
Collaboration LMHRH with the GHPP VaccTrain brings workable structures and processes
Dr. James D. K. Goteh, Head of the Pharmacovigilance & Clinical Trials Division at LMHRA, also gave an overview of the development of the processes in the agency since it received the mandate for clinical trial oversight by the Liberia Medicines and Health Products Regulatory Authority Act in 2010. He equally highlighted the successful collaboration with the VaccTrain project, “Our partnership with the GHPP VaccTrain project, has helped us significantly improve our CTO activities. Most of the gaps we identified were addressed according to our priorities,” said Goteh. He highlighted three areas in particular:
- The newly developed `Clinical Trials Regulation’, the modified `Clinical Trials Guideline’, plus several other tools, standard procedures and forms that are now available.
- Training of 5 LMHRA staff members at the RCORE* in Ghana
- Development of further regulatory documents for clinical trial oversight and integration of AVAREF* forms
Sources and further information
News Article on the Launch:
- FPA – Front Page Africa, August, 03, 2022: “Liberia: LMHRA Advances Step to Guide Clinical Trial of Medicines”
- RCORE means Regional Centres of Regulatory Excellence. They are designated by AUDA-Nepad and dedicated to strengthen human capacities in several regulatory functions. The RCORE Ghana at FDA Ghana offers a 3-weeks Training in Clinical Trials Oversight.
- AVAREF: The African Vaccine Regulatory Forum (AVAREF) is a network of African national regulatory authorities and ethics committees that uses harmonization and reliance as pillars for capacity building.
For further Information, kindly contact us via e-mail: vacctrain@pei.de
Date: October 2022
