In the field of pharmacovigilance, Periodic Safety Update Reports (PSURs) are essential tools for monitoring the long-term safety and effectiveness of pharmaceuticals once they are on the market. In Indonesia, the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) relies on PSURs to ensure ongoing drug safety and to make informed regulatory decisions. This article explores the role, process, and significance of PSURs in the Indonesian pharmacy system, along with the challenges and recent advancements in this area. Visit pafikotaargamakmur.org.

The Role of PSURs

Ensuring Continuous Drug Safety

PSURs are critical for assessing the safety profile of a drug after it has been approved and is available to the public. Unlike pre-market clinical trials, which may not capture all potential adverse effects, PSURs provide ongoing data on the safety and efficacy of drugs as they are used in broader, real-world populations.

Updating Safety Information

PSURs help …