Indonesia BPOM Revises Drug Registration Rules to Streamline Timelines and Labeling

Summary of the Update 

BPOM Regulation No. 23 of 2025, signed on August 1 and effective from August 12, 2025, revises Regulation No. 24 of 2017. The update focuses on three critical areas: drug evaluation timelines, biological product definitions, and drug labeling requirements. 

The regulation establishes differentiated evaluation timelines based on product type and urgency. For instance, emergency use authorization for generic drugs now requires only five days of review, while new drugs addressing life-threatening conditions or rare diseases (Orphan Drugs) will be evaluated within 100 days. 

Definitions of biological products have been expanded to include enzymes, monoclonal antibodies, hormones, vaccines, plasma derivatives, recombinant DNA products, and advanced therapies such as gene therapy drugs. 

Labeling standards have been updated to require more detailed information, including expiration dates after opening or reconstitution for specific dosage forms such as eye drops and lyophilized powders. 

The regulation also refines registration pathways for administrative variations, new indications or posology changes, and the transition from emergency use authorization to full market approval. 

Feedback Deadline 

All existing drug labels must be updated to comply with the revised requirements by August 12, 2027. Exceptions apply to halal certification labeling, which is managed under separate regulations.

Why It Matters

These amendments aim to accelerate patient access to essential therapies, especially in emergency or rare-disease contexts, while aligning Indonesia’s regulatory framework with internationally recognized systems. By redefining product categories and refining label requirements, BPOM enhances regulatory clarity and minimizes administrative burden for the industry. 

Who Should Take Note

This update is especially relevant for regulatory affairs teams, quality assurance functions, product development teams, and market access professionals managing drug registrations in Indonesia. Companies dealing with biological products and time-sensitive approvals will be most affected.

Next Steps

Stakeholders should: 

• Review existing product classifications against the expanded definitions. 
• Audit current labels to plan updates before the compliance deadline. 
• Align regulatory strategies with expedited review opportunities in reference countries, including the US, EU, Japan, Canada, Australia, Switzerland, and the UK. 

To stay ahead of evolving requirements, companies should adopt systems that support timely global regulatory monitoring, documentation, and submission management.  

RegASK is an AI-driven solution for Regulatory Intelligence and Workflow Orchestration helping life sciences and consumer packaged goods companies stay ahead of changing global regulations and guidelines with predictive insights. It combines smart documentation, automated workflows, and integrated experts to enable faster adaptation, which ultimately reduces operational risk.

FAQs

It is an amendment to Indonesia’s drug registration rules, updating evaluation timelines, product definitions, and labeling requirements, effective August 12, 2025.

Emergency use authorization for generic drugs now follows a five-day review, while new orphan or life-threatening drugs are evaluated within 100 days. 

Labels must now include details such as expiration dates after opening or reconstitution for certain dosage forms like eye drops and lyophilized powders. 

RegASK helps regulatory teams monitor updates, streamline documentation, and ensure timely compliance with labeling under the new regulation.