Recently, Indonesia’s National Agency of Drug and Food Control (BPOM) has published a draft regulation governing the Procedures for the Approval of Preclinical Study Implementation for Natural Medicines, Quasi-drugs, Health Supplements, and Cosmetics for public consultation, and stakeholders may submit feedback via https://bit.ly/Masukan-PPUPK by the deadline of October 16, 2026.
The draft regulation systematically sets out the full-process requirements for the Preclinical Study Implementation Approval (PPUPK), covering application, evaluation, decision, validity period, reporting, and supervision, and applies to four product categories: natural medicines, quasi-drugs, health supplements, and cosmetics. CIRS Group hereby summarizes the key provisions of the draft relevant to cosmetics for reference.
Key Provisions of the Draft (Points Relevant to Cosmetics)
Obligation to apply:
- Natural medicines, quasi-drugs, and health supplements undergoing preclinical studies in Indonesia must obtain a PPUPK issued by BPOM in advance.
- For cosmetics undergoing preclinical studies in Indonesia, applicants may apply for a PPUPK. An application must satisfy three conditions simultaneously: approval has been obtained from an ethics committee.
- The preclinical study has not yet been initiated; and the study data will be used to fulfill product registration or notification requirements.
Types of studies:
- Preclinical studies comprise in vivo preclinical toxicity studies and preclinical pharmacodynamic studies.
- Notably, the draft specifies that, apart from in vivo toxicity studies, the safety and efficacy evaluation of cosmetics may employ other preclinical study methods that do not involve laboratory animals, providing a regulatory basis for non-animal alternative methods such as in vitro testing.
Applicants and procedures:
- Companies and research institutions may file electronic applications via BPOM’s dedicated PPUPK platform.
- Fees must be settled within 10 calendar days after payment notification. BPOM delivers evaluation results within a maximum of 20 working days from payment, under a clock-stop mechanism: the review timeline pauses when supplementary information is requested and resumes upon the applicant’s submission.
Cosmetics application dossier (Annex I of the draft):
- application letter stating application purpose;
- preclinical study protocol (acute, subchronic/chronic toxicity, pharmacodynamic studies;
- relevant special toxicity tests including carcinogenicity and teratogenicity where applicable;
- research-team composition;
- non-human cosmetics safety testing is classified as special toxicity);
- ethics-committee approval;
- product formula;
- ingredient CoAs;
- intended product claims;
- test-sample quality documentation.
Timelines and fees:
- Supplementary data shall be submitted within 100 working days upon receipt of BPOM’s clarification request.
- If this deadline cannot be met, applicants are required to provide an action plan, explanation of impediments and committed timeline, and update BPOM on progress every 100 working days.
- Non-compliance voids the application with paid fees non-refundable. BPOM issues electronic approval or rejection decisions via its official platform; fees for rejected applications are also non-refundable.
Validity period:
- A PPUPK is valid for 2 years from issuance. For studies extending beyond this term, an extension request with justification shall be filed prior to expiry; otherwise, a fresh application is needed.
Supervision and transitional arrangements:
- BPOM oversees preclinical studies to ensure adherence to approved protocols and data integrity; violations may trigger administrative actions including technical guidance and warnings.
- Preclinical studies commenced before this regulation’s promulgation shall achieve compliance within 12 months thereafter. The regulation enters into force on its promulgation date.
Implications for Cosmetics Companies
- Clarify the scope of obligations: Unlike the mandatory approval for natural medicines, quasi-drugs, and health supplements, preclinical studies on cosmetics in Indonesia fall under the “may apply” category for a PPUPK. However, if the study data is intended to support product registration or notification, the preconditions — including ethics approval and the study not yet having commenced — must still be met. Early communication with BPOM to confirm applicability is recommended;
- Leverage non-animal alternative methods: The draft explicitly allows cosmetics to use test methods that do not involve laboratory animals. Companies planning safety/efficacy evaluations in Indonesia are advised to prioritize alternative approaches such as in vitro methods, balancing data compliance with the global “cruelty-free” trend;
- Prepare quality and ethics documentation in advance: Ethics committee approval is a precondition for application; test samples must be supported by quality documentation, and additional time should be reserved for import approval where test samples are to be imported;
- Manage timelines strictly: Pay close attention to key deadlines -payment (10 calendar days), clarification responses (100 working days), the post-study report (30 working days), and the validity period (2 years). Missing deadlines may result in the application being voided, loss of fees, or administrative warnings.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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