Post-Market Surveillance in the Indonesian Pharmacy System
Post-market surveillance (PMS) is a critical aspect of the pharmaceutical regulatory framework, ensuring that drugs remain safe, effective, and of high quality after they enter the market. In Indonesia, the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) is the primary regulatory body responsible for overseeing post-market surveillance. This article provides an in-depth look at the post-market surveillance process in Indonesia, its significance, methodologies, challenges, and recent advancements. Visit pafikotaargamakmur.org
The Importance of Post-Market Surveillance
Post-market surveillance is essential for several reasons:
- Safety Monitoring: Ensures that any adverse drug reactions (ADRs) or side effects that were not identified during clinical trials are detected and managed promptly.
- Quality Assurance: Verifies that pharmaceutical products continue to meet quality standards throughout their lifecycle.
- Regulatory Compliance: Ensures ongoing compliance with regulatory requirements and Good Manufacturing Practices (GMP).
- Public Health Protection: Protects public health by identifying and addressing