Published on August 19, 2025, by the Indonesian National Agency of Drug and Food Control (BPOM), Regulation No. 23 of 2025 introduces major amendments to drug registration criteria and procedures. The regulation updates evaluation timelines, clarifies biological product classifications, and adjusts labeling requirements to align with international standards.
更新摘要
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， 和 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 基因治疗 药物.
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.
反馈截止日期
All existing drug labels must be updated to 遵守 the revised requirements by August 12, 2027. Exceptions apply to halal certification labeling, which is managed under separate regulations.
为什么重要
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.
谁应该注意
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.
下一步
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 是人工智能驱动的监管情报和工作流程编排解决方案 helping life sciences and consumer packaged goods companies stay ahead of changing global regulations and guidelines with predictive insights. 它结合了智能文档、自动化工作流程和集成专家 to enable faster adaptation, which ultimately reduces operational risk.
常见问题解答
What is BPOM Regulation No. 23 of 2025?
It is an amendment to Indonesia’s drug registration rules, updating evaluation timelines, product definitions, and labeling requirements, effective August 12, 2025.
What are the new evaluation timelines for drug registration?
Emergency use authorization for generic drugs now follows a five-day review, while new orphan or life-threatening drugs are evaluated within 100 days.
What labeling changes are required?
Labels must now include details such as expiration dates after opening or reconstitution for certain dosage forms like eye drops and lyophilized powders.
如何 RegASK support companies with BPOM compliance?
RegASK helps regulatory teams 监视器 updates, streamline documentation, and ensure 及时 compliance with labeling under the new regulation.
