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 Safety, Quality, and Export Import Control of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances, which is under Deputy of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances Control.

Within this Directorate, there are 4 (four) Sub-Directorate, they are Sub-Directorate of Safety Control of  Drugs, Narcotics, Psychotropics, and Precursors, Sub-Directorate of Export Import Control of Drugs, Narcotics, Psychotropics, and Precursors, Sub-Directorate of Quality, Information and Promotion Control of Drugs, Narcotics, Psychotropics, and Precursors, and Sub-Directorate of Tobacco Control

Drug safety contol and its monitoring are task for Sub-Directorate of Safety Control of  Drugs, Narcotics, Psychotropics, and Precursors. 

In performing these tasks, this Sub-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, 

Pharmacovigilance Team

National Agency of Drug and Food Control

Indonesia