BPOM Working on New Draft Regulation on the Special Access Scheme for Drug Imports

In order to ensure access to drugs for which proper distribution permits have yet to be secured but which are urgently needed in relation to public health, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is currently preparing a Draft Regulation on Imports of Drugs and Drug Materials under the Special Access Scheme (“Draft Regulation”). Once the Draft Regulation has been promulgated, the new Special Access Scheme (“SAS”) which will address the importation of drugs and drug-related materials without the need to secure distribution permits (“SAS Drugs”) will be implemented.