PHARMACOVIGILANCE & CLINICAL TRIALS

PHARMACOVIGILANCE UNIT

As enshrined in Part III, Count 5 of the LMHRA Act, the Authority is charged with the responsibility to conduct or facilitate necessary research and development, promote Pharmacovigilance, and disseminate timely drug information.

The Pharmacovigilance (PV) Unit is established to monitor the safety of all medicines and health products in Liberia and to share these reports with the international body. In 2013, the LMHRA met the basic requirements of the World Health Organization (WHO) International Drug Monitoring Program thereby becoming the 112th Official Member and at the same time gained the status of a National Pharmacovigilance Center (NPC).

The guideline for the National Pharmacovigilance System in Liberia has been developed to complement and support the efforts of educating all healthcare workers on this important concept and enhance their efforts in ensuring that safe, efficacious and quality medicines are made available to the entire Liberian populace.

Activities

Roll out Adverse Drug Reaction (ADR) forms to various health facilities and conduct training for health care workers in adverse drug reporting.

Coordinate with other health programs including the Expanded Program for Immunization (EPI), National AIDS Control Program (NACP) and other vertical programs to collect ADR reports.

Report to the World Health Organization (WHO) International Drug Monitoring Program

CLINICAL TRIAL UNIT

CT Validation & CTA Assessment Forum

As enshrined in the Act establishing the LMHRA all clinical studies involving humans and animals shall be authorized by LMHRA in accordance with Part V, Section 5 counts 1 & 2 as stated below.
No person/organization shall conduct clinical studies in humans or animals of medicines or health products without the authorization of the Authority.
The conditions for authorization of such clinical studies shall be stipulated in regulations promulgated by the Authority that shall provide for the issuance, renewal, suspension, cancellation and revocation of such authorizations.
Considering the aforementioned, the Clinical Trials Unit at the LMHRA is established with the responsibility to:
Receive and assess all Clinical Trial applications (CTA) submitted at the LMHRA.
Conduct Good Clinical Practice (GCP) inspection at trial sites to ensure compliance in line with the LMHRA regulatory requirements and International best practices
Review all reports from CT sites and advise management on appropriate regulatory actions
Investigate the conduct of Clinical Trials
Suspend or stop Clinical Trials (depending on the magnitude of the offense)
Specifically, the Clinical Trials Unit performs the following activities:
Receives and processes all clinical trials applications (CTA) for review
Conducts GCP inspection at trials sites
Conducts GCP training for inspectors and study team
Serves as secretariat for the Scientific Advisory Committee on clinical trials
Reviews importation permits for investigational products that are required for the conduct of clinical trials
Conducts pre- submission meetings to discuss issues related to application processes
Reviews all reports (safety reports, quarterly reports, Serious Adverse Events-SAE reports and final or close-out reports from clinical trials conduct.

The Clinical Trials Unit is headed by Dr. Juwe D. Kercula who is one of the Authors of the LMHRA first clinical trials guidelines. Dr. Kercula coordinates the VaccTrain/RegTrain Project of the GHPP at the LMHRA which partnership has developed the LMHRA CT vital documents. Dr. Kercula has represented the LMHRA on several international meetings on Clinical Trials including the SCoMRA 2019 where he served as one of the speakers on Clinical Trials.