Through harnessing innovations in its regulatory processes, including digital transformation in health care, BPOM is advancing toward achieving WHO Listed Authority status, a key milestone on Indonesia's pathway to becoming a trusted source of pharmaceutical products across the globe.
n a rapidly advancing world shaped by technology and globalization, the regulatory landscape for medicines and biotech products must evolve to keep pace with growing challenges and opportunities.
Around the globe, regulatory agencies, policymakers and industry stakeholders are increasingly focused on ensuring that people have reliable access to safe, effective and high-quality medicines. This shared commitment reflects recognition of the critical role that healthcare innovation and regulatory excellence play in protecting public health and driving economic stability across nations.
As a critical component of Indonesia's health system, the Food and Drug Monitoring Agency (BPOM) is responsible for ensuring the safety, quality and efficacy of medicines and processed foods across the archipelago.
The agency’s mission extends beyond public health protection: BPOM plays a vital role in fostering sustainable growth in the country’s health and economic sectors. Its regulatory framework aligns with international standards, guided by principles of excellence, adaptability and global best practices. The overarching goal is to create an Indonesia where safe and high-quality pharmaceutical products are accessible to all.
In recent years, BPOM has reached significant milestones that reinforce its standing as a respected regulatory authority. The agency holds Maturity Level 3 status, with certain functions recognized at Maturity Level 4 by the World Health Organization (WHO), a testament to its commitment to international standards.
This recognition strengthens Indonesia's regulatory foundation in areas such as clinical trial authorization, licensing, inspections and pharmacovigilance. Building on these achievements, BPOM is advancing toward becoming a WHO Listed Authority (WLA), a step that will solidify Indonesia’s position in the global regulatory landscape.
Becoming a WLA is both ambitious and necessary, and requires not only meeting but also exceeding international standards. Achieving this status will enable Indonesia to become a trusted source of pharmaceutical products worldwide, enhancing export potential and attracting international investments.
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