The drug registration and approval process in Indonesia is a critical component of the nation’s healthcare system, ensuring that all pharmaceutical products available in the market are safe, effective, and of high quality. This process is primarily overseen by the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM), in collaboration with the Ministry of Health (Kementerian Kesehatan) and other stakeholders. This article provides a detailed overview of the drug registration and approval process in Indonesia, highlighting its key stages, regulatory requirements, challenges, and recent developments. Visit pafikotaargamakmur.org.

Regulatory Bodies Involved

Indonesian Food and Drug Authority (BPOM)

BPOM is the primary regulatory body responsible for overseeing the drug registration and approval process. It ensures that all pharmaceutical products meet the required safety, efficacy, and quality standards before they can be marketed in Indonesia. BPOM’s responsibilities include:

1. Evaluation and Approval: Reviewing applications for new drugs and granting