PHARMACOVIGILANCE & CLINICAL TRIALS

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.