Ensuring Continuous Drug Safety in the Indonesian Pharmacy System
Ensuring continuous drug safety is a cornerstone of public health and pharmacovigilance. In Indonesia, the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) plays a pivotal role in monitoring and safeguarding the safety and efficacy of pharmaceuticals throughout their lifecycle. This article explores the mechanisms and strategies employed by BPOM to ensure ongoing drug safety, highlighting key processes, challenges, advancements, and future directions. Visit pafikotaaekkanopan.org
The Role of BPOM in Drug Safety
Regulatory Oversight
BPOM is responsible for regulating pharmaceuticals, from their development and approval to their post-market surveillance. This involves a comprehensive framework designed to ensure that drugs are safe, effective, and of high quality. BPOM’s regulatory oversight includes:
- Drug Approval: Evaluating clinical trial data and drug formulations to ensure safety and efficacy before a drug is approved for the market.
- Manufacturing Standards: Ensuring that pharmaceutical manufacturing processes adhere to Good Manufacturing Practice (GMP)