Indonesia's National Agency of Drug and Food Control (NA-DFC)
The NA-DFC is a legislative and law enforcement agency that regulates pharmaceuticals and medical devices in Indonesia. The agency crafts legislation and regulations to promote the standardization of pharmaceuticals and medical devices.
The agency also oversees the licensing and certification of pharmaceuticals and medical devices. Under the NA-DFC, the Deputy of Therapeutic Products and Narcotics, Psychotropic and Addictive Substance Control is the sector responsible for pre-market evaluations of drugs and devices, including inspections of manufacturing sites to ensure Good Manufacturing Practice (GMP), and post-market surveillance activities once products have been licensed. These include product sampling, laboratory testing, and inspections of manufacturing and distribution facilities. This sector is supported by several other departments, including the National Committee on Drug Evaluation, National Committee on Medical Devices Evaluation and the Evaluation Committee on Promotion of Over the Counter Drugs.
Within the NA-DFC, the National Laboratory of Drug and Food Control is responsible for procedure development and testing to assure quality standards are met with regards to drugs and medical devices. The Center of Food and Drug Investigation performs inquests of suspected fraud and misconduct related to those products.
The NA-DFC supports research and development for the pharmaceutical and medical device industries, and carries out its own research on the implementation of its policies. In order to promote public health, the NA-DFC disseminates informational materials on the selection and safe use of drugs and devices. The NA-DFC also evaluates all product advertisements and promotions.
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