Vigilance
The Pharmacovigilance and Clinical Trials Division is responsible for:
Monitoring the safety, quality, and performance of regulated products by receiving, assessing, investigating, and managing adverse events (AEs), adverse events following immunization (AEFI), and reports of suspected substandard and falsified (SF) products throughout their lifecycle considering the scope of regulated products under Drugs Department.
Conducting signal detection and management, and reviewing Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs), and recommending appropriate regulatory actions.
Conducting Good Pharmacovigilance Practice (GVP) inspections to verify compliance with applicable regulatory requirements and monitoring the implementation of corrective and preventive actions (CAPA) from GVP inspections findings.
Coordinating and overseeing regulatory actions relating to safety and quality concerns, including product recalls, recall audit activities, withdrawals, , risk minimization measures, and collaboration with relevant divisions on enforcement actions.
Reviewing and evaluating clinical trial applications and amendments, overseeing the conduct of approved clinical trials, maintaining the national clinical trial register, and taking appropriate regulatory actions for non-compliant clinical trials in accordance with applicable legal, regulatory and ethical requirements.
Regulating and analysing product information used in labeling, promotion, advertising and marketing of products regulated under the scope of Drugs Department by reviewing and approving promotional materials and ensuring compliance with applicable legal and regulatory requirements.
Promoting the safe, appropriate, and rational use of regulated products through medicines safety communications, public awareness initiatives, and measures to prevent drug and substance abuse.
Develop regulatory guidance, standards, and reporting systems, and strengthen pharmacovigilance, post-marketing surveillance, clinical trial oversight, and product information systems through stakeholder engagement and capacity building.
Coordinate national vigilance systems and collaborate with national, regional, and international partners, including WHO, the Uppsala Monitoring Centre (UMC), and other regulatory authorities, to strengthen information sharing, regulatory harmonization, and adoption of international best practices.