Indonesia

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways
3. Available Drugs

Regulatory Overview

Indonesia is regulated by the BPOM (Badan Pengawas Obat dan Makanan). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

BPOM (Badan Pengawas Obat dan Makanan)

Regulatory Pathways (1)

BPOM Special Access Scheme (SAS) – Indonesia 30 days

Indonesia's BPOM Special Access Scheme allowing import and use of unregistered medicines for patients with serious or life-threatening conditions on a named patient basis.

Application Form: BPOM SAS Form

Legal Basis: Government Regulation No. 72/1998

Eligibility: Serious or life-threatening condition with no locally registered alternative

Reference: BPOM Drug Regulation

Drugs Available (1)

Drug	Access Route	Status	Lead Time
diethylcarbamazine	—	—	—

Indonesia

ISO Code	`ID`
Region	Southeast Asia
Regulatory Authority	BPOM (Badan Pengawas Obat dan Makanan)
Pathways	1 documented
Drugs Available	1 drug(s)