The Food and Drug Supervisory Agency (BPOM) recently issued Regulation No. 23 of 2025, updating the Criteria and Procedures for Drug Registration. This marks the fifth amendment to Regulation No. 24 of 2017 and was enacted on August 1, 2025, officially promulgated on August 12, 2025.

Some key points of the new regulation include the following:

The definition of “Biological Product” has been broadened to include products derived from humans, animals, or microorganisms, produced through conventional or biotechnological methods. The scope now explicitly covers enzymes, monoclonal antibodies, hormones, vaccines, plasma-derived drugs, recombinant DNA products, immunoserum, secretomes, extracellular vesicles, cell-derived products without cells, and advanced therapy products (somatic cell therapy, tissue-engineered products, and gene therapy).

Introduction of the definition of “Emergency Use Authorization (EUA),” which was not included in the previous regulation. It is defined as the authorization for the use of a drug during a public health emergency, whether the drug is unapproved or approved for a different indication

The new timeline for registration, including Emergency Use Authorization (EUA), Registration Variations, New Drug Development (Obat Pengembangan Baru), and Generics.

Addition of information requirements for labeling, including halal certification, narcotic classification logos, and radioactive symbols, on product packaging such as outer packaging, catch covers/envelopes, labels, blister/strip packs, and ampoule/vial labels.

Industry Outlook

With this new regulation, advanced therapy products, secretomes, extracellular vesicles, and cell-derived products without cells are now classified as biological products requiring registration and can no longer be conducted solely as service-based research. The clearer evaluation timeline at BPOM creates opportunities for new product investment in Indonesia through accelerated registration pathways, enhancing local industry competitiveness. The industry must also adapt to new labeling requirements, which may require investment for implementation.