Vaccines, Vigilance And Clinical Trials

The Vaccines, Vigilance and Clinical Trials Directorate (VVCTD) is a Directorate under the Health Products and Technologies Division (HPTD), a Division within the Food and Drugs Authority. The mandate of the Directorate is to protect public health and safety through the regulation of Vaccines, Blood and Biologics, the conduct of Clinical Trials and the safety monitoring of regulated Health Products and Technologies. In addition to its core regulatory function, the Directorate is actively involved in capacity-building programmes leveraging the RCORE platform and developed training manuals. VVCTD consists of three Departments.

Vaccines and Biological Products Department

Vaccines and Biological Product Department (VBPD) mandate is to evaluate vaccines and biological products applications towards the granting of marketing authorization, and process for appropriateness and subsequent approval, post-approval variations /changes.  In addition, the Lot Release function of the FDA resides with VBPD and the Centre for Laboratory Services and Research (CLSR).  VBPD evaluates the scientific and technical product development data submitted by manufacturers to determine whether the product meets the minimum regulatory standards for Quality, Safety and Efficacy published in relevant FDA guidelines for either product registration/marketing authorization or post-approval variations/changes or lot release. In addition, the Department regulates Blood Facilities through the inspection and licensing of the Blood Facilities, and the listing of blood components prepared by the facility. VBPD operates an evaluation and approval process that maximizes the benefits and minimizes the risks to patients of its scope of regulated products. It is a Regional Centre of Regulatory Excellence (RCORE) for vaccine Marketing Authorization (MA).

Safety Monitoring Department

Safety Monitoring Department (SMD) hosts the National Pharmacovigilance Centre. The Centre joined the WHO Programme for International Drug Monitoring (PIDM) in November 2001 as the 65th member of the Programme. SMD’s mandates are safety monitoring of health products and technologies, awareness creation amongst patients (consumers), and healthcare professionals on the need to report adverse reactions. The Department is also involved in the vetting and approval of advertisement for drugs, cosmetics and household chemical substances and medical devices. Further, SMD is the secretariat for two Technical Advisory Committees (TAC) for the safety of Medicines, and Vaccinees and Biological Products. SMD is a Regional Centre of Regulatory Excellence (RCORE) for Pharmacovigilance.

Clinical Trials Department
Clinical Trials Department (CTD) leverages Part 8 of the Public Health Act 2012, Act 851 to enforce its mandate for Clinical Trials (CT). The mandate of the Department includes the authorization of CTs, the conduct of Good Clinical Practice (GCP) inspections of approved trials and the use of other modern regulatory measures to achieve the highest standard for the conduct of trials in compliance with the principles of GCP. CTD is the Secretariat for the Technical Advisory Committee for CT, and a distinguished RCORE for the oversight of the conduct of Clinical Trials. As an RCORE, CTD has trained more than 70 regulators from over 14 African countries. In addition, the Department offers GCP training for local clinical trial researchers and tertiary institutions.