New Draft Framework for Preclinical Trials of Natural Medicines, Quasi-Medicines, Health Supplements, and Cosmetics in Indonesia

Indonesia is preparing a more structured regulatory framework for preclinical trials of natural medicines, quasi-medicines, health supplements, and cosmetics through a draft regulation of the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan or “BPOM”).

The draft introduces a dedicated approval mechanism for preclinical trials through an Approval for Implementation of Preclinical Trials (Persetujuan Pelaksanaan Uji Praklinik or “PPUPK”). Under the proposed framework, PPUPK would generally be required for preclinical trials conducted in Indonesia involving natural medicines, quasi-medicines, and health supplements for registration purposes, while a more flexible approach would apply to cosmetics.

The draft also introduces a specific pathway for cosmetic preclinical testing using methods that do not involve test animals.

Because the regulation remains in draft form, the final scope, requirements, procedures, and implementation may differ from the provisions currently proposed.

1. A Dedicated BPOM Framework for Preclinical Trials

The draft is intended to establish a specific regulatory framework for preclinical trials conducted in Indonesia in connection with natural medicines, quasi-medicines, health supplements, and cosmetics.

The proposed framework would place greater emphasis on BPOM oversight before preclinical testing begins. For the relevant product categories, preclinical testing intended to support product registration would generally need to be preceded by the required approval.

This approach would complement the existing BPOM framework governing clinical trials. The existing clinical-trial regime already establishes a separate approval mechanism, known as PPUK, for certain products. The draft would introduce a similar regulatory structure at the preclinical stage through PPUPK.

The proposed framework is therefore intended to provide a clearer regulatory pathway from preclinical testing through subsequent product registration and, where applicable, clinical testing.

2. PPUPK Requirements for Natural Medicines, Quasi-Medicines, and Health Supplements

Under the draft, PPUPK would be required before certain preclinical trials conducted in Indonesia for natural medicines, quasi-medicines, and health supplements.

The proposed requirement is particularly relevant where preclinical testing is undertaken to generate safety or efficacy data needed for product registration.

This would mean that businesses and research institutions could not simply commence the relevant preclinical studies and address BPOM approval afterwards. The proposed framework places the approval process before implementation of the trial.

The approach is consistent with the direction of existing BPOM regulations, under which certain product categories require preclinical and/or clinical evidence as part of the regulatory assessment process.

The draft would therefore provide a more specific administrative mechanism for BPOM to review and approve the proposed preclinical testing before it is conducted.

3. A More Flexible Approach for Cosmetics

Cosmetics are treated differently under the draft.

For cosmetics, PPUPK would be available as an approval mechanism for preclinical trials conducted in Indonesia, but the draft proposes that obtaining PPUPK would not be mandatory in the same manner as for natural medicines, quasi-medicines, and health supplements.

This distinction is consistent with the different regulatory treatment of cosmetics under the existing BPOM framework. Cosmetic regulation primarily focuses on product safety, quality, ingredients, contaminants, and the substantiation of product benefits.

The proposed optional PPUPK pathway could nevertheless provide cosmetics businesses and research institutions with a formal mechanism for placing certain preclinical testing activities under BPOM oversight.

The precise circumstances in which voluntary PPUPK would be useful would depend on the final regulation and the nature of the testing and product claims involved.

4. Non-Animal Preclinical Testing for Cosmetics

One of the notable features of the draft is its recognition of preclinical testing methods that do not involve test animals for cosmetics.

Under the proposed framework, cosmetic safety and benefit assessments may be supported by preclinical methods that do not use animals, subject to the applicable scientific and regulatory requirements.

This could potentially accommodate scientifically validated alternative methodologies, including in vitro, in silico, or other recognized testing approaches, depending on the final technical requirements established by BPOM.

The proposed approach is relevant to cosmetic manufacturers and research institutions seeking to generate safety or benefit data while reducing reliance on animal testing.

The recognition of non-animal methods does not, however, mean that any alternative testing method would automatically be accepted. The suitability and scientific validity of the method would remain relevant to the regulatory assessment.

5. Ethics Approval and Preclinical Trial Approval

The draft places ethics approval within the regulatory process for preclinical testing.

For trials involving the use of test animals, the relevant ethics approval would need to be obtained before the preclinical trial is implemented. The draft also follows the direction of BPOM’s recent framework on in vivo toxicity testing, which requires ethical oversight for animal-based toxicity studies.

For the PPUPK mechanism, the proposed requirements would also include confirmation that the preclinical trial has not yet been implemented when the application is submitted.

This creates a sequencing requirement in which the necessary approvals should be addressed before the relevant testing begins.

The final interaction between ethics approval, PPUPK, and other technical requirements will depend on the final regulation and the applicable type of preclinical study.

6. Who May Apply for PPUPK

The draft allows PPUPK applications to be submitted by business actors and research institutions.

This reflects the practical structure of preclinical research, where testing may be conducted directly by a product owner or by a research institution engaged by the relevant sponsor.

The applicant would be responsible for submitting the required information concerning the proposed trial and ensuring that the relevant supporting documentation is available for BPOM’s assessment.

The arrangement is broadly consistent with the existing regulatory approach for clinical trials, where responsibility for regulatory submissions may rest with the relevant sponsor or organization responsible for the research.

7. Application and BPOM Evaluation Process

The draft proposes that PPUPK applications be submitted electronically through BPOM’s designated service system.

Where the electronic system experiences technical problems, the draft contemplates the possibility of using another submission mechanism in accordance with BPOM’s procedures.

The application would be subject to the applicable state revenue fee. The draft proposes that the fee be paid within the prescribed period following BPOM’s issuance of the relevant payment order.

After payment, BPOM would evaluate the application and may involve experts where necessary to assess the proposed preclinical trial.

The draft proposes an evaluation period of 20 working days using a time-to-respond mechanism. Where BPOM requests corrections or additional information, the evaluation period would stop and would resume after the applicant submits the requested information.

This mechanism is intended to establish a defined administrative timeframe while allowing BPOM to request clarification or additional supporting material where necessary.

8. Corrections and Additional Information

The draft provides a defined period for applicants to respond to requests for corrections or additional information.

Applicants would generally have up to 100 working days to provide the requested material.

Where the applicant is unable to complete the requested corrections or provide the additional information within that period, the draft contemplates the submission of an action plan explaining the relevant circumstances and setting out a target completion date.

Progress would then be reported periodically in accordance with the proposed framework.

This mechanism provides applicants with a structured process for addressing deficiencies identified during BPOM’s review rather than treating an incomplete submission as automatically closed.

9. Validity and Changes to PPUPK

Under the draft, an approved PPUPK would be valid for two years from the date of issuance.

Where an extension is required, the applicant would need to submit an extension request before the approval expires and provide the relevant scientific justification.

The draft also regulates changes to preclinical trial documents after PPUPK has been issued.

Where changes are made to the approved trial documentation, the proposed amendment would need to be submitted to BPOM together with the relevant justification. BPOM would then evaluate the proposed changes under the applicable review procedure.

This would allow BPOM to maintain oversight over material changes to an approved preclinical trial rather than treating the original approval as covering all subsequent modifications.

10. Requirements for Investigational Products

The draft also introduces requirements concerning the quality and supporting documentation of products used in preclinical trials.

For products containing natural materials, the proposed requirements may include the identification of appropriate chemical markers and supporting data from pilot-scale production batches.

The purpose of these requirements is to provide greater assurance that the product used in the preclinical study is sufficiently characterized and that relevant quality parameters can be identified.

The specific documentation required would depend on the commodity and the nature of the product under investigation.

11. Reporting Following Completion of the Trial

The draft proposes a post-trial reporting obligation for business actors and research institutions.

Following completion of a preclinical trial, a scientific data summary would need to be submitted to BPOM within the prescribed period.

The reporting obligation would also apply where a trial is terminated before completion, in which case the reasons for early termination would need to be reported.

This requirement would create a regulatory record of the outcome of preclinical testing and would allow BPOM to maintain information concerning studies conducted under the PPUPK framework.

12. Relationship with Existing BPOM Regulations

The proposed PPUPK framework would operate alongside existing BPOM regulations governing the registration and safety assessment of natural medicines, quasi-medicines, health supplements, and cosmetics.

For natural medicines, existing rules already contemplate the use of preclinical and/or clinical evidence depending on the type of product and the claims being supported.

For health supplements and quasi-medicines, existing BPOM regulations also establish safety, quality, and efficacy requirements that may involve supporting testing.

For cosmetics, the existing framework focuses primarily on product safety and quality, including requirements concerning ingredients, contaminants, and product information. The proposed PPUPK mechanism would add a specific regulatory pathway for preclinical testing without necessarily converting all cosmetic preclinical testing into a mandatory approval process.

The draft should therefore be understood as an additional layer governing the conduct of preclinical trials rather than as a replacement for the existing product-specific registration and safety requirements.

13. Relationship with Clinical Trial Approval

The proposed PPUPK framework would also complement BPOM’s existing clinical-trial approval regime.

For products subject to mandatory clinical-trial approval, PPUK applies at the clinical stage, while PPUPK would address the relevant preclinical stage under the proposed framework.

For cosmetics, the existing clinical-trial framework already provides a more flexible approach under which PPUK may be applied for in certain circumstances. The draft adopts a comparable approach for preclinical testing by allowing PPUPK to be obtained voluntarily for cosmetics.

The two approval mechanisms should nevertheless be distinguished. PPUPK concerns preclinical testing, while PPUK concerns clinical trials involving human subjects or other activities falling within the clinical-trial framework.

14. Practical Implications for Businesses and Research Institutions

If adopted in its current form, the draft would require businesses and research institutions conducting preclinical studies in Indonesia to pay closer attention to the regulatory status of the product and the type of testing being undertaken.

For natural medicines, quasi-medicines, and health supplements, companies planning preclinical studies for registration purposes would need to consider the PPUPK requirement before commencing the relevant testing.

For cosmetics, businesses would have greater flexibility because PPUPK is proposed as an optional approval mechanism. The availability of non-animal testing methods may also provide additional options for generating safety and benefit data, subject to scientific validation and the final requirements established by BPOM.

Applicants would also need to plan for the administrative timelines associated with PPUPK, including the evaluation period, response to requests for additional information, validity period, amendment procedures, and post-trial reporting.

These requirements may become particularly relevant when preclinical testing forms part of a broader product registration or development timeline.

Conclusion

The draft BPOM regulation would introduce a more structured framework for preclinical trials involving natural medicines, quasi-medicines, health supplements, and cosmetics in Indonesia.

The proposed framework would generally require PPUPK for relevant preclinical trials conducted in Indonesia for natural medicines, quasi-medicines, and health supplements, while providing a voluntary PPUPK pathway for cosmetics.

The draft also expressly contemplates non-animal preclinical testing for cosmetics, subject to the applicable scientific and regulatory requirements.

In addition, the proposed framework would establish procedures for application, BPOM evaluation, correction of documents, validity and extension of PPUPK, amendments to approved trial documents, and reporting following completion of the trial.

As the regulation remains in draft form, businesses should treat these provisions as proposed requirements rather than requirements that are already in force. The final text and any implementing guidance should be monitored before companies make compliance decisions based solely on the current draft.

This alert is part of a series examining regulatory developments affecting pharmaceutical, natural medicine, health supplement, and cosmetic businesses in Indonesia. Please feel free to contact us should you wish to discuss these developments further.

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