Regulatory Affairs and Pharmacovigilance in Indonesia: A Practical Guide for Pharma Companies
Introduction Indonesia is an important market for pharmaceutical and healthcare companies seeking to expand across Southeast Asia. However, market entry involves more than preparing a product dossier. Companies must understand national registration requirements, demonstrate product quality, and maintain effective safety-monitoring systems after authorization. The National Agency of Drug and Food Control, known as BPOM, oversees the regulation of medicines in Indonesia. Regulatory affairs and pharmacovigilance (PV) therefore need to operate as connected functions. Registration establishes the basis for market access, while ongoing safety and quality oversight helps protect patients and maintain compliance. 1. Understanding Indonesia’s Regulatory Framework BPOM is the principal authority responsible for regulating medicines, including product registration and post-market supervision. Companies should identify the applicable product category and current regulatory pathway before pre...