Lead Executive Office Profile
The Pharmacovigilance and Clinical Trials Control (PVCT) Lead Executive Office is a section under the Deputy Director General of the Medicine Sector, is responsible for regulation of clinical trials, and monitoring of quality, safety and effectiveness of medicines. The focus of this section are Clinical Trials Control, Pharmacovigilance (PV) and Post Marketing Surveillance (PMS), and Rational Drug Use and Drug Information.
The section collaborates with other sections such as inspection and enforcement, medicine evaluation and marketing authorization, medicine quality control, branch offices, and other organizations particularly if there are quality or safety issues to be addressed where regulatory actions need to be undertaken. It also collaborates with the Communication and Public Relation in sensitizing the public and health professionals on issues related to the quality and safety of medicines.
The PVCT LEO plays the following roles in regulation of medicines and protection of the general public:
1. Clinical Trials Control
- Review and assessment of applications to conduct clinical trials. This involves evaluation of clinical trials protocol including preclinical studies, clinical data and quality of investigational products
- Approval of clinical trial application as per the laws and guidelines
- Inspection of clinical trial sites to ensure clinical trials are conducted in compliance with Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), clinical trials regulations, guidelines, standard operating procedures (SOPs), and internationally accepted standards
- Update and maintain National Clinical Trials Registry.
- Review and evaluate all safety information raised from clinical trials
- Review and evaluate progress reports of all approved clinical trials
- Attend and respond to all customer enquiries regarding conduct of clinical trials
- Collaborates with national ethics committee and other stakeholders
2. Pharmacovigilance
- Receive adverse drug reactions (ADRs), medication errors, quality defects, Adverse Events Following Immunization (AEFI) from the healthcare workers and the community; and conducting causality assessment of the received reports
- Public education on safety of medicines
- Sensitization of public and healthcare workers on reporting of suspected Adverse Events associated to the use of medicines
- Review of safety reports of medicines like Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs) and Risk Management Plans (RMP)
- Communication with Marketing Authorization Holders on all matters related to safety of medicines
- Establishment and coordination of Regional Pharmacovigilance Offices
- Collaboration with stakeholders (Universities, research institutes, public health programs) in strengthening PV system
3. Post Marketing Surveillance
- Plan, coordinate and conduct post marketing surveillance of medicines
- Coordinate the national PMS task force
- Attend and respond to all customer enquiries regarding post marketing surveillance