Indonesia’s New Regulatory Framework for Drug Promotion and Advertising

Issue 24, June 2026

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) has recently issued BPOM Regulation No. 7 of 2026 on Drug Promotion and Advertising (“BPOM Reg. 7/2026”), which revokes and replaces BPOM Regulation No. 2 of 2021 (“BPOM Reg. 2/2021”). The issuance of BPOM Reg. 7/2026 introduces a new regulatory framework for drug promotion and advertising in Indonesia, including expanded provisions on drug promotion activities, revised procedures for obtaining advertising approvals, and the introduction of additional prohibitions relating to the promotion and advertising of pharmaceutical products.

Our advisory below focuses primarily on the drug promotion aspects introduced under BPOM Reg. 7/2026, as the advertising-related provisions generally remain consistent with those previously regulated under BPOM Reg. 2/2021.

Drug Promotions and New Actors of Drug Promotions and Advertising

BPOM Reg. 7/2026 now expressly regulates drug promotion, which was not specifically addressed under BPOM Reg. 2/2021. Under the new regulation, drug promotion can be conducted for drug which already obtained marketing authorization (izin edar). Further, drug promotion must meet the following criteria:

1. objective, by providing information that is accurate and consistent with the approved efficacy and safety profile of the drug based on the latest approved labelling;
2. complete, by providing product information in accordance with the approved marketing authorization; and
3. not misleading, by ensuring that the information provided is truthful, accurate, accountable, does not create misleading impressions or perceptions, and does not encourage irrational use of drugs or create health risks.

In addition, BPOM Reg. 7/2026 expands and clarifies the categories of parties permitted to conduct drug promotion activities, which now include not only pharmaceutical industries, but also pharmaceutical wholesalers (pedagang besar farmasi – “PBF”), pharmaceutical service facilities (fasilitas pelayanan kefarmasian) [1], pharmaceutical electronic system operators (penyelenggara sistem elektronik farmasi) and other facilities.

Risk Management

BPOM Reg. 7/2026 also introduces a risk management framework for drug promotion activities, differentiated based on the type of business actor conducting the promotion. For pharmaceutical industries and PBF, the implementation of risk management must form part of their quality management system in the application of good manufacturing practices and/or good distribution practices. Such risk management must take into account the risks arising from promotional activities in order to prevent misuse and/or irregularities in drug distribution within the community.

Meanwhile, pharmaceutical service facilities, pharmaceutical electronic system operators, and other facilities conducting promotional activities are only required to implement risk management measures aimed at preventing misuse and/or irregularities in drug distribution within the community.

In both cases, the risk management measures are required to focus on stock management aspects, including estimated demand and disease prevalence, drug shelf life, supply chain integrity, and return or non-return purchase policies.

General Overview on the Requirements for Drug Promotions

BPOM Reg. 7/2026 further clarifies the scope and implementation of drug promotion activities. Under the new regulation, prescription drug promotions may only be directed to medical personnel and healthcare professionals, while promotions for non-prescription drugs may also target the general public.

The regulation also introduces qualification requirements for medical representatives, sales personnel, and marketing personnel of pharmaceutical industries, PBF, and other relevant parties involved in promotional activities. These personnel are expected to possess adequate competencies relating to the promoted products, communication, marketing, pharmacovigilance, and other relevant areas, with the specific qualifications to be determined internally by each respective business actor.

In addition, BPOM Reg. 7/2026 emphasizes that pharmaceutical industries, PBFs, pharmaceutical service facilities, pharmaceutical electronic system operators, and other facilities remain responsible for all promotional statements and activities carried out on their behalf. These parties are also required to follow up and report any drug safety information received from the public or healthcare professionals through the applicable pharmacovigilance and reporting mechanisms.

Notably, the regulation now expressly recognizes sponsorship arrangements by pharmaceutical industries and PBFs to medical personnel and/or healthcare professionals as one form of permitted promotional activities, subject to the requirements under the regulation.

Drug Advertising

Similar to BPOM Reg. 2/2021, BPOM Reg. 7/2026 also states that drug advertising may only be conducted by pharmaceutical industries. PBF and other pharmaceutical service facilities are no longer permitted to independently conduct drug advertising and may only do so based on a cooperation with the relevant pharmaceutical industry. Accordingly, the pharmaceutical industries are liable for the drug advertisement they made but is published by other parties. Furthermore, the application for Advertising Approval may only be submitted by the pharmaceutical industry itself.

Integration of Advertising Approval

BPOM Reg. 7/2026 now integrates the issuance process for drug advertising approvals through the Online Single Submission system, which is electronically connected to BPOM’s official advertising approval platform, which we understand to be SIAPIK BPOM.

Prohibitions of Drug Promotion and Advertisement

BPOM Reg. 7/2026 introduces broader restrictions on drug promotion and advertising activities applicable to pharmaceutical companies, PBF, pharmaceutical service facilities, pharmaceutical electronic system operators, and other related facilities.

Under the new regulation, these parties are prohibited from directly or indirectly providing bonuses, gifts, cash, free products, or other incentives linked to pharmaceutical sales to the public, healthcare professionals, medical practitioners, including their families and affiliates.

The regulation also prohibits several promotional practices deemed inconsistent with ethical pharmaceutical marketing, including:

1. cooperation arrangements relating to drug prescriptions with healthcare facilities or healthcare professionals to increase sales;
2. multi-level marketing or similar sales schemes;
3. promotional programs involving prizes, quizzes, or used packaging returns;
4. disguised promotional activities conducted through clinical trials, marketing studies, or similar research activities;
5. distribution of free drug samples to the public;
6. bonus schemes involving free pharmaceutical products;
7. excessive discounts resulting in unfair competition; and
8. commission-based discount arrangements.

In addition, BPOM Reg. 7/2026 imposes stricter controls on prescription drug promotion. Pharmaceutical service facilities, pharmaceutical electronic system operators, and other facilities are prohibited from promoting prescription drugs to the public. Pharmaceutical electronic system operators are also prohibited from displaying prescription drug information, including product names, packaging, or images, for advertising or direct sales purposes accessible to the public.

The regulation further restricts the use of social media by prohibiting two-way communication features from being used as tools for direct drug sale transactions. Lastly, individuals are generally prohibited from independently conducting pharmaceutical promotions or advertisements, except where they are formally appointed by a pharmaceutical company as advertising talent or endorsers.

Transitional Period

BPOM Reg. 7/2026 came into effect on 29 April 2026, and business actors are granted a 12-month transition period until 29 April 2027 to align the advertising of its products which was previously approved under BPOM Regulation No. 2 of 2021 if the current advertising is not in line with the requirement under BPOM Reg. 7/2026.

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1. A Pharmaceutical service facilities consist of (i) hospital pharmacy installations; (ii) clinic pharmacy installations; and (iii) pharmacies.

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If you have any questions, please contact

1. Maria Sagrado, Partner - maria.sagrado@makarim.com
2. Budhy Apriastuti Evita, Senior Associate - budhy.apriastuti@makarim.com
3. Muhammad Alfitras Tavares, Associate - alfitras.tavares@makarim.com

_{M&T Advisory is a digital publication prepared by the Indonesian law firm, Makarim & Taira S. It informs generally on the topics covered and should not be treated as legal advice or relied upon when making investment or business decisions. Should you have any questions on any matter contained in M&T Advisory, or other comments in general, please contact us at the emails provided at the end of this article.}