BPOM Restructures Clinical Trial Procedures under BPOM Regulation Number 34 of 2025

Introduction

On December 31, 2025, the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, “BPOM”) issued Regulation of the Indonesian Food and Drug Authority Number 34 of 2025 on the Amendment to Regulation of the Indonesian Food and Drug Authority Number 8 of 2024 on Clinical Trial Approval Procedures (“BPOM Regulation 34/2025”).

Based on its considerations, BPOM Regulation 34/2025 was issued to adjust provisions on clinical trial procedures. BPOM further establishes technical provisions for clinical trials set out in the annexes based on each commodity, including Cosmetics, Natural Medicines, Health Supplements, and Processed Food, as well as licensing provisions for clinical trial activities in the Pharmaceutical sector.

Comparison

BPOM Regulation 34/2025 introduces changes to several provisions in Regulation of the Indonesian Food and Drug Authority Number 8 of 2024 on Clinical Trial Approval Procedures (“BPOM Regulation 8/2024”). The table below sets out a comparison between BPOM Regulation 34/2025 and BPOM Regulation 8/2024:

Key Provisions

Pharmaceutical Sector: Post-Marketing Study Permit Provisions

Article 6 paragraph (1a) reflects a renumbering of the provision previously regulated under Article 6 paragraph (2) of BPOM Regulation 8/2024 and reaffirms the exemption from PPUK obligations for post-marketing clinical trials conducted for education and supervision purposes. Activities not intended for additional claims or product registration do not require PPUK from BPOM and continue to be implemented based on Ethical Committee approval. This provision simplifies the fulfillment of licensing obligations and the administrative management of clinical trial activities in the Pharmaceutical sector.

Natural Medicine Sector: Product Development Provisions

Annex II regulates Natural Medicine product development provisions based on ingredient characteristics and submitted claims, grouped as follows:

1. Products with a history of use in Indonesia: For jamu or herbal products with a history of use in Indonesia that do not undergo changes in dosage or method of use, Annex II provides for possible exemptions from certain toxicity and pharmacodynamic tests.

2. Products with new ingredients or new claims: For Natural Medicine products using new ingredients or proposing new claims, Annex II requires the implementation of pre-clinical and clinical trials in stages. Clinical trials are conducted with appropriate designs to control bias, including through randomization and the use of control groups.
   

Health Supplements Sector: Product Claim Provisions

Provisions for proving Health Supplement claims are regulated based on the type of claim submitted, as listed in Annex III of BPOM Regulation 34/2025, grouped as follows:

1. General Claims or Nutrition Claims: Claim substantiation is conducted in accordance with applicable provisions for general claims or nutrition claims.

2. Functional Claims and Risk Reduction Claims: Claim substantiation is conducted through clinical trials with appropriate designs to assess the benefits of active substances, including the use of Randomized Controlled Trial (“RCT”) designs. Clinical trial data analysis is used to support claims stated on product labels.

Processed Food Sector: Health Claim Provisions

Provisions for proving health claims for Processed Food are regulated through clinical trials as listed in Annex IV of BPOM Regulation 34/2025. For health benefit claims, testing is conducted using randomized controlled trial or RCT designs. The clinical trial protocol contains the following provisions:

1. Primary Endpoint: Assessment is conducted on health parameters that can be measured objectively.

2. Subject Compliance Control: The protocol regulates mechanisms to monitor subject compliance in consuming products according to dosage provisions during the trial period.

Cosmetics Sector: Risk and Ethical Provisions

Cosmetic clinical trial implementation provisions are regulated based on risk classification and ethical approval as listed in Annex IIIa of BPOM Regulation 34/2025. The Annex regulates product risk criteria and ethical approval mechanisms as follows:

1. High-risk products: Require approval from an Independent Ethical Committee if used on sensitive areas, contain nanomaterials or new ingredients with undocumented safety history, involve invasive procedures, or involve subjects from vulnerable groups.

2. Low-risk products: Those not included in high-risk criteria, such as cleansers, moisturizers, fragrances, and decorative cosmetics, may obtain ethical approval from an Internal Ethical Committee. Annex IIIa regulates the requirements for establishing an Internal Ethical Committee, including member composition, involvement of lay members unaffiliated with the company, and provisions on independence from the research team.

3. Prohibition on internal subjects: Regulated in Annex IIIa Letter B Number 2, which prohibits the use of cosmetic industry employees or sponsor employees as clinical trial subjects for the respective company's products.

General Obligations of Businesses (Sponsors)

General provisions for Businesses as clinical trial sponsors apply to all commodities and refer to provisions stipulated in BPOM Regulation 34/2025, with the following arrangements:

1. Electronic System Validation: Sponsors validate electronic data systems used in clinical trial implementation.

2. Serious Adverse Event (SAE) Reporting: Sponsors submit reports on serious adverse events according to the established reporting timeframe, including reporting within 24 hours of the event becoming known.

3. Responsibility for Data Quality: Sponsors are responsible for the quality and reliability of clinical trial data, including the implementation of activities involving third parties, such as Contract Research Organizations (CROs).

Closing

BPOM Regulation 34/2025 regulates the implementation of clinical trials through adjustments to licensing provisions, ethical approval, and technical requirements applied based on the characteristics of each commodity. In the Pharmaceutical sector, this regulation provides for the exemption from Clinical Trial Approval (PPUK) obligations for certain post-marketing clinical trials conducted for education or health care facility supervision purposes. For Natural Medicines and Health Supplements, clinical trial provisions are adjusted to the type of ingredients and claims submitted, including the differentiation of substantiation requirements for products with known history of use and products with new ingredients or claims. In the Processed Food sector, this regulation regulates health claim substantiation through clinical trials with adequate methodology. Meanwhile, Cosmetic clinical trial implementation is regulated based on product risk classification and ethical approval mechanisms, including the prohibition on using company employees as clinical trial subjects. In addition to sector-specific regulations, this regulation also establishes general obligations for Businesses as clinical trial sponsors, covering clinical trial data management and validation, serious adverse event reporting, and responsibility for quality and compliance of clinical trial implementation in accordance with statutory provisions.