02 Oct 2026 · TAMA Insight
Indonesia Updates Preclinical In Vivo Toxicity Testing Guidelines
Indonesia has introduced a new framework governing preclinical in vivo toxicity testing through Food and Drug Supervisory Agency Regulation No. 14 of 2026 on Guidelines for Preclinical In…
Indonesia has introduced a new framework governing preclinical in vivo toxicity testing through Food and Drug Supervisory Agency Regulation No. 14 of 2026 on Guidelines for Preclinical In Vivo Toxicity Testing (“BPOM Regulation 14/2026”). The regulation provides an updated reference for the conduct and evaluation of in vivo toxicity studies for products subject to the supervision of the Food and Drug Supervisory Agency (BPOM), while replacing the previous framework under BPOM Regulation No. 10 of 2022.
Effective from 24 August 2026, BPOM Regulation 14/2026 establishes the regulatory framework for toxicity testing, including the applicable testing guidelines, ethical approval requirements, BPOM approval for certain categories of products, and the use of scientifically validated and internationally recognised testing methodologies.
Scope of the New Framework
BPOM Regulation 14/2026 applies to in vivo toxicity testing conducted by businesses in the drug and food sector and research institutions. The products covered include drugs, traditional medicines, quasi-drugs, health supplements, cosmetics, and processed food.
The regulation defines preclinical in vivo toxicity testing as testing conducted on laboratory animals to identify toxic effects within biological systems and obtain dose-response information from the test substance. The framework is therefore directed at generating safety data that may be relevant to the assessment of products before their use in humans.
For businesses developing or producing products within the scope of the regulation, the new framework provides a common regulatory reference for designing toxicity studies and preparing the resulting safety data. It also provides BPOM with a reference for evaluating whether the safety aspects of a product have been adequately supported by the proposed testing protocol and the resulting toxicity data.
A Broader Set of Testing Guidelines
The regulation provides guidance on a broad range of preclinical toxicity studies, covering acute, subchronic, and chronic oral toxicity, as well as teratogenicity, skin sensitisation, eye irritation, acute dermal irritation and corrosion, vaginal mucosal irritation, acute and subchronic dermal toxicity, carcinogenicity, and inhalation toxicity.
The detailed requirements applicable to each type of study are set out in the Appendix to BPOM Regulation 14/2026, which forms an integral part of the regulation. Accordingly, the Appendix should be considered together with the main provisions when designing a toxicity study or assessing whether an existing testing protocol remains appropriate under the new regulatory framework.
This is relevant for companies and research institutions with ongoing or planned studies, particularly where the toxicity data will subsequently be submitted to BPOM as part of a broader product safety assessment.
Ethical Approval as Part of the Testing Process
BPOM Regulation 14/2026 expressly requires businesses and research institutions conducting in vivo toxicity testing to obtain approval from an ethics committee.
The ethics committee is contemplated as an independent institution comprising medical or scientific professionals as well as non-medical or non-scientific members with expertise relevant to preclinical testing. Its role includes responsibility for the welfare of animals used in preclinical testing.
The requirement places ethical review within the regulatory framework for toxicity testing itself. Accordingly, the planning and implementation of an in vivo toxicity study must take into account not only the scientific design of the study, but also the applicable ethical approval process.
Additional BPOM Approval for Certain Products
For traditional medicines, quasi-drugs, and health supplements, BPOM Regulation 14/2026 establishes an additional regulatory requirement. In these cases, obtaining approval from an ethics committee is not sufficient. The party conducting the toxicity study must also obtain approval from BPOM to conduct the preclinical study in accordance with the applicable regulatory requirements.
The framework therefore creates two distinct approval requirements for these product categories: ethical approval from the relevant ethics committee and approval from BPOM for the conduct of the preclinical study. The procedure for obtaining BPOM approval is to follow the service standards established by BPOM.
For businesses developing products within these categories, the distinction is relevant to the preparation and scheduling of preclinical studies. The required approvals should be addressed before the relevant testing is undertaken, rather than treated solely as part of the subsequent submission of safety data.
Recognition of International Testing Methodologies
The new framework also provides room for the use of scientific and internationally recognised testing methodologies. In addition to the toxicity testing guidelines set out under BPOM Regulation 14/2026, businesses and research institutions may refer to validated methods supported by reliable scientific references and to other toxicity testing standards or methodologies applicable internationally.
This approach provides flexibility where a company is conducting product development or toxicity studies under protocols that also apply in other jurisdictions. However, the use of an international methodology remains subject to the applicable requirements under the Indonesian framework, including the relevant ethical and regulatory approval requirements.
For companies operating across jurisdictions, the provision may therefore be relevant when assessing whether an existing testing protocol can be used to support regulatory requirements in Indonesia or whether adjustments are required before the study is conducted or submitted to BPOM.
Transitional Treatment and Replacement of the Previous Regulation
BPOM Regulation 14/2026 also addresses studies and submissions that were already underway when the new regulation took effect. Applications for approval to conduct preclinical toxicity testing, as well as submissions of toxicity testing data, that were made before the effective date of BPOM Regulation 14/2026 continue to be processed under BPOM Regulation No. 10 of 2022.
This transitional arrangement distinguishes between applications submitted under the previous framework and new applications made after the new regulation became effective. The timing of an application or submission is therefore relevant when determining which regulatory framework applies.
At the same time, BPOM Regulation 10 of 2022 has been expressly revoked upon the effectiveness of BPOM Regulation 14/2026. As a result, the new regulation now provides the principal framework for preclinical in vivo toxicity testing within the scope of BPOM supervision, subject to the transitional treatment for matters already submitted under the previous regulation.
Implications for Businesses and Research Institutions
The replacement of the previous framework means that businesses and research institutions involved in preclinical toxicity testing should review their existing testing arrangements against the new requirements.
For planned studies, this includes considering whether the proposed study falls within the scope of BPOM Regulation 14/2026, whether the testing protocol is consistent with the applicable guidelines, and whether the necessary ethical approval and, where applicable, BPOM approval have been obtained before the study proceeds.
For ongoing studies, the relevant issue may be whether the study or related submission falls within the transitional provision. Companies may also need to consider whether existing protocols, supporting documentation, and testing methodologies remain appropriate under the new framework, particularly where the resulting data will be used for regulatory purposes in Indonesia.
The ability to rely on validated scientific methods and internationally applicable testing methodologies may also be relevant for companies conducting product development across multiple jurisdictions. In such cases, the regulatory assessment should consider not only whether the methodology is scientifically recognised, but also whether the study satisfies the Indonesian requirements applicable to the relevant product and testing process.
A New Reference Point for Preclinical Safety Assessment
BPOM Regulation 14/2026 provides an updated regulatory reference for preclinical in vivo toxicity testing across a broad range of products under BPOM supervision. Its significance lies not only in replacing the previous toxicity testing guidelines, but also in bringing together the scientific, ethical, and regulatory aspects of conducting and evaluating toxicity studies.
For businesses, compliance therefore extends beyond selecting the appropriate type of toxicity test. The design of the study, ethical approval, BPOM approval where required, methodology, and preparation of supporting safety data all form part of the regulatory considerations surrounding preclinical testing.
Companies and research institutions with ongoing or planned toxicity studies should therefore assess the applicable requirements under BPOM Regulation 14/2026, particularly where the resulting data will support a future regulatory submission or product safety assessment in Indonesia.
This alert is part of a series examining recent developments in Indonesia’s healthcare, pharmaceutical, and food and drug regulatory framework. Please feel free to contact us should you wish to discuss these developments further.
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