Health Product Vigilance Center
Health Product Vigilance Center (HPVC) has the duty and responsibility to monitor the safety of health products after their approval. The HPVC’s activities include health product signal detection and assessment as well as health product’s risks/benefits assessment by referring to scientific evidence and safety reports received by the HPVC, for the purpose of determining further appropriate measures for risk management. In addition, the HPVC also cooperates internationally in information sharing and works together in developing and strengthening the health product vigilance system to ensure Thai consumer safety in using these products.
The health product vigilance system in Thailand is carried out through networks which consist of both public and private healthcare facilities thorough the country at all levels, from primary to trinary, the number of which is more than 1,000, as well as pharmacies, marketing authorization holders, premises registrants and specification providers, with each member performing the role of monitoring any adverse event and reporting back to the HPVC.
The HPVC has a database called “Thai Vigibase” which collects all health product safety reports, namely reports of adverse events resulting from the use of health products of an individual patient (Individual Case Safety Report: ICSR), device defect and field safety corrective action reports for medical devices. The database receives reports from marketing authorization holders, premises registrants, specification providers, healthcare professionals, and consumers.