The Regulatory Framework for Pharmaceuticals in Indonesia: Challenges and Advancements
The regulatory framework for pharmaceuticals in Indonesia plays a crucial role in ensuring the safety, efficacy, and quality of medicines available to the public. As a diverse archipelago with a growing population, Indonesia faces unique challenges in regulating its pharmaceutical industry. This article explores the current regulatory landscape for pharmaceuticals in Indonesia, the challenges faced, and the advancements being made to improve the regulatory environment. Visit pafikotametro.org
Overview of the Regulatory Framework
- National Agency of Drug and Food Control (BPOM)
The National Agency of Drug and Food Control (BPOM) is the primary regulatory authority responsible for overseeing the pharmaceutical industry in Indonesia. Established in 1999, BPOM’s mandate includes the regulation, supervision, and control of drugs and food products to ensure public safety.
BPOM’s responsibilities encompass a wide range of activities, including:
- Drug Registration: Ensuring that pharmaceuticals meet safety, efficacy, and quality standards before they are approved for market.
- Quality