BPOM (Badan Pengawas Obat dan Makanan) is Indonesia’s national drug and food regulatory authority, commonly rendered in English as the Indonesian Food and Drug Authority. No clinical trial can be conducted in Indonesia without BPOM authorization, obtained under BPOM Regulation No. 8 of 2024 on Procedures for Approval of Clinical Trial Implementation, which replaced the earlier Regulation No. 21 of 2015. On December 31, 2025, BPOM issued Regulation No. 34 of 2025, an amendment to that framework. It is worth being precise about what changed: Regulation No. 34 of 2025 is specifically a cosmetic-clinical-trial amendment — it adds a dedicated risk-based approval pathway and guideline appendix for cosmetic product trials, rather than overhauling BPOM’s clinical trial approval process across the board. This guide explains BPOM’s general clinical trial approval framework and exactly what the 2025 update does and doesn’t change.
What BPOM regulates, and who needs its approval
BPOM is Indonesia’s counterpart to bodies like the US FDA or Health Canada: it authorizes drugs and other regulated health and consumer products for the Indonesian market and oversees the clinical trials that generate the evidence behind them. Regulation No. 8 of 2024 governs the approval procedure for clinical trials involving cosmetics, processed food, health supplements, natural/traditional medicines (obat tradisional), and quasi-drugs, in addition to conventional pharmaceutical and biologic products, which had already been within the scope of BPOM’s clinical-trial-approval authority under the prior 2015 regulation. In practice, this means a broader range of sponsors — not just pharmaceutical companies, but cosmetics and consumer-health manufacturers making efficacy or safety claims — now sit inside a formal BPOM clinical trial authorization pathway rather than a lighter-touch or informal one.
For research administrators used to a US-centric frame, the closest conceptual anchor is the FDA’s Investigational New Drug (IND) pathway or Health Canada’s Clinical Trial Application (CTA) — see CASRAI’s Canada clinical trial regulatory framework guide for that comparison. BPOM’s approval is the Indonesian equivalent gate: a sponsor cannot import, test, or administer an investigational product to human subjects in Indonesia without it.
The general BPOM clinical trial approval process (Regulation No. 8 of 2024)
Regulation No. 8 of 2024 sets out a documentation-driven approval procedure broadly similar in shape to other national authorization pathways:
- Submission. The sponsor (or a locally appointed contract research organization acting on the sponsor’s behalf) submits a clinical trial application package to BPOM, including the protocol, investigator’s brochure or equivalent product information, and supporting documentation on the test product.
- Administrative and technical review. BPOM reviews the submission for completeness and scientific/technical adequacy. Regulatory-intelligence trackers monitoring BPOM’s published procedures report a standard review period of up to 20 working days from the date a complete application is received, after which BPOM issues its decision — treat this as the general benchmark rather than a guaranteed timeline for every submission, and confirm current processing expectations directly with BPOM or local regulatory counsel before building a project timeline around it.
- Ethics approval, in parallel. As in most GCP-aligned jurisdictions, BPOM authorization is necessary but not sufficient on its own — the trial also needs approval from a relevant ethics committee, the Indonesian equivalent of an Institutional Review Board (IRB). Neither authorization substitutes for the other.
- Ongoing obligations. Once a trial is authorized, Regulation No. 8 of 2024 also sets requirements for test-product handling, serious adverse event reporting, clinical trial implementation reporting, and BPOM’s continuing supervision of trial conduct, with administrative penalties available for non-compliance.
BPOM also built in a compliance transition: sponsors or CROs already conducting trials before the regulation’s effective date (May 21, 2024) were given a defined window to bring existing trials into line with the new procedure. Anyone managing a trial that predates the 2024 update should confirm its transition status directly with BPOM rather than assuming automatic grandfathering.
What Regulation No. 34 of 2025 actually changes
Regulation No. 34 of 2025 amends Regulation No. 8 of 2024 specifically to build out a formal approval pathway for cosmetic clinical trials — an area the base 2024 regulation named as in-scope but had not yet detailed with product-specific guidance. Cosmetic clinical trials in Indonesia remain voluntary in the sense that not every cosmetic product requires one; a trial becomes necessary when a manufacturer wants to make a specific efficacy or safety claim (anti-aging effects, SPF/sun-protection claims, use in sensitive areas, or similar) that needs scientific substantiation before it can be marketed. Key elements of the 2025 amendment, per BPOM’s own published regulation and regulatory-intelligence reporting on it:
- A risk-tiered ethics review model. Higher-risk cosmetic trials (those involving sensitive body areas, specific higher-risk ingredients, SPF testing, or anti-aging claims) require full external ethics committee review. Lower-risk cosmetic trials may instead be approved through an internal ethics committee, provided the sponsor meets the applicable regulatory conditions.
- A dedicated guideline appendix. The amendment adds Appendix IIIa — Cosmetic Clinical Trial Guidelines — sitting alongside the general Good Clinical Practice guidance in Appendix I of the base regulation, so a cosmetic trial sponsor now has to satisfy both the general GCP framework and the cosmetic-specific appendix.
- Electronic systems and reporting expectations carried into the cosmetic context. Sponsors are expected to validate any electronic systems used in trial conduct, consistent with the data-integrity expectations that already applied under the base regulation.
The regulation was promulgated and took effect on December 31, 2025. Because this is a narrowly scoped amendment rather than a rewrite of BPOM’s general clinical trial procedure, sponsors of conventional pharmaceutical, biologic, food-supplement, or traditional-medicine trials should not expect Regulation No. 34 of 2025 to change the process described in the section above — its effect is concentrated in the cosmetic-trial pathway.
Ethics committee review under BPOM’s framework
BPOM’s approval and Indonesian ethics committee approval are separate, parallel requirements — a structure CASRAI’s content on other jurisdictions describes as a near-universal feature of GCP-aligned regulatory systems (see the IRB vs. ethics committee comparison for how this dual-review structure is usually described in English-language regulatory literature). What Regulation No. 34 of 2025 adds that is genuinely distinctive is the explicit two-tier structure for cosmetic trials specifically: full external ethics committee review for higher-risk study designs, and a defined internal-ethics-committee pathway for lower-risk ones. Sponsors should not assume this same risk-tiering applies outside the cosmetic-trial context unless BPOM issues comparable guidance for other product categories.
How BPOM’s framework compares to other national pathways
For research administrators coordinating multi-country trials that include Indonesian sites, the practical takeaway is the same one that applies across jurisdictions: a BPOM authorization for Indonesian sites does not substitute for, and is not substituted by, an authorization obtained elsewhere. A trial running sites in Indonesia and, say, the US or Canada needs BPOM approval for the Indonesian sites in addition to an FDA IND or Health Canada Clinical Trial Application for the other jurisdictions, even where the underlying protocol is identical. See CASRAI’s guides on the Canadian clinical trial regulatory framework and the UK’s 2026 clinical trials regulation reform for how two other national pathways structure this same underlying authorization-plus-ethics-review requirement, and CASRAI’s Good Clinical Practice guide for the ICH E6 conduct standards that BPOM-regulated trials, like trials in most ICH-aligned jurisdictions, are expected to follow.
Practical considerations for sponsors and research administrators
- Confirm which product category your trial falls into before assuming a timeline. BPOM’s clinical trial approval framework now spans pharmaceuticals/biologics, cosmetics, processed food, health supplements, natural/traditional medicines, and quasi-drugs — and, as of Regulation No. 34 of 2025, cosmetic trials specifically carry their own risk-tiered ethics pathway that other categories do not.
- Don’t assume Regulation No. 34 of 2025 applies to your trial just because it’s recent and widely reported. Its scope is cosmetic clinical trials; a pharmaceutical or supplement trial sponsor should keep working from the base Regulation No. 8 of 2024 framework unless BPOM issues a comparable update for that category.
- Sequence BPOM authorization and ethics committee review in parallel, not sequentially — as in most GCP-aligned jurisdictions, neither approval substitutes for the other, and both need to conclude before enrollment can begin.
- Verify current requirements directly with BPOM or qualified local regulatory counsel before finalizing a submission. Indonesian regulatory practice, like most national frameworks, is amended incrementally; treat any specific fee, form, or timeline detail as subject to confirmation against BPOM’s current published requirements at the time of filing.
Frequently asked questions
What does BPOM stand for, and what does it regulate?
BPOM stands for Badan Pengawas Obat dan Makanan — Indonesia’s National Agency of Drug and Food Control, commonly referred to in English as the Indonesian Food and Drug Authority. It regulates the safety, quality, and marketing authorization of drugs, biologics, cosmetics, processed food, health supplements, and traditional medicines in Indonesia, including authorizing the clinical trials that support claims about those products.
Is Regulation No. 34 of 2025 a general overhaul of BPOM’s clinical trial approval process?
No. It is a targeted amendment to Regulation No. 8 of 2024, adding a dedicated approval pathway and guideline appendix (Appendix IIIa) for cosmetic clinical trials specifically. The general approval process for other product categories, including pharmaceuticals, continues to run under the base Regulation No. 8 of 2024 framework.
Does every cosmetic product sold in Indonesia require a clinical trial?
No. Cosmetic clinical trials in Indonesia are generally required only when a manufacturer wants to make a specific efficacy or safety claim (for example, anti-aging or SPF claims) that needs scientific substantiation, rather than being a universal precondition for market entry.
How long does BPOM take to review a clinical trial application?
Regulatory-intelligence sources tracking BPOM’s published procedures report a standard review period of up to 20 working days from receipt of a complete application under Regulation No. 8 of 2024, after which BPOM issues its decision. Confirm current timelines directly with BPOM before building a project plan around this figure, since processing times can vary by submission completeness and product category.
Does BPOM approval replace the need for ethics committee approval in Indonesia?
No. BPOM authorization and ethics committee approval are separate, parallel requirements, and a trial cannot begin on the strength of either one alone — both must be obtained.
For the broader clinical-research regulatory landscape this guide sits within, see the clinical research pillar page.
