National Agency of DRUG and Food Control (NADFC) Indonesia has mandate to ensure that all marketed drug are fullfilling safety, efficacy and quality requirements. NADFC conducts pre-market and post-market control on drug comprehensively.
Specific for ensuring drug safety of marketed drug, NADFC has assigned a unit to perform this task. This unit is Directorate of Distribution Control of Therapeutic and Household Healthcare Products, which is under Deputy of Therapeutic, Narcotics, Pssichotropics, and Addictive Substances Control.
Within this Directorate, there are 3 (three) Sub-Directorate, they are Sub-Directorate of Inspection and Certification of Distribution Facilities; Sub-Directorate of Promotion and Labelling Control, and Sub-Directorate of Surveillance and Risk Analysis of Therapeutic and Household Healthcare Products.
Drug safety contol and its monitoring are task for Sub-Directorate of Surveillance and Risk Analysis of Therapeutic and Household Healthcare Products. in performing these tasks, this Su-Directorate is supported with some staffs. To encounter the challenges in pharmacovigilance, additional staffs are needed and improvement of their knowledge capacity must be encouraged. This would help NADFC to develop and implement pharmacovigilance further in the next future in Indonesia.
Best warm regards,
National Agency of Drug and Food Control