On 16 April 2026, the Head of the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan or “BPOM“) issued BPOM Regulation No. 7 of 2026 on Drugs Promotion and Advertising (“BPOM Reg. 7/2026“), which was promulgated on 29 April 2026 and came into force on that date. BPOM Reg. 7/2026 revokes and replaces BPOM Regulation No. 2 of 2021 on Guidelines for the Supervision of Drug Advertising, and was issued to implement Article 425 (2) of Government Regulation No. 28 of 2024 on the Implementing Regulation of Law No. 17 of 2023 on Health, and to adjust the drug advertising supervision framework to developments in health law, risk-based business licensing for the drug and food subsector, and evolving media and methods used for the marketing and/or trading of drugs.
Pharmaceutical companies, wholesalers, pharmacies, and electronic pharmacy platforms operating in Indonesia face a much more detailed set of rules under BPOM Reg. 7/2026 than under the regulation it replaces, covering everything from advertising content and media to the approval process and what commercial practices are off-limits. Businesses that market or advertise drugs in Indonesia should start reviewing their promotional materials and approval workflows now, well ahead of the 12-month transition deadline.
We set out below the key provisions introduced under BPOM Reg. 7/2026:
Scope of Promotion and Advertising Activities
BPOM Reg. 7/2026 defines “Promotion” (Promosi), as a marketing activity, including the provision of information and/or appeals concerning a drug, conducted to increase the prescription, distribution, sale, and/or use of the drug, and “Advertising” (Iklan), which is a form of Promotion consisting of a communicated message about a drug directed at its target audience, in the form of image, text, sound, audio-visual, or other form, delivered through various means for marketing and/or trading purposes (Article 1 (2) and (3) of BPOM Reg. 7/2026). Further, only the pharmaceutical industry, wholesalers (Pedagang Besar Farmasi or “PBF“), pharmaceutical service facilities (hospital pharmacy installations, clinic pharmacy installations, and pharmacies), electronic pharmacy system providers, and/or other facilities authorized to dispense drugs may conduct Promotion and/or Advertising, and only for drugs that have obtained marketing authorization (persetujuan izin edar) (Article 2 (1) and Article 3 of BPOM Reg. 7/2026).
Drug Classification Determines Permitted Audience
Drugs are classified into prescription drugs (further divided into hard drugs, narcotics, and psychotropics) and non-prescription drugs (further divided into over-the-counter drugs and limited over-the-counter drugs) (Article 4 of BPOM Reg. 7/2026). Prescription drugs may only be promoted and/or advertised through media intended for medical and/or health personnel, while non-prescription drugs may be promoted and/or advertised to the general public (Article 5 of BPOM Reg. 7/2026).
Promotion of prescription drugs specifically directed at medical and/or health personnel must be delivered only through forums or information media with restricted access to such personnel, and must be scientifically substantiated and not misleading; permitted media include scientific brochures, professional presentations, or digital technology used for drug detailing (e-detailing) (Article 9 of BPOM Reg. 7/2026). Prescription drugs may still be published on a pharmaceutical company’s official website as part of its company profile, but such publication is limited to product packaging images, trade name, composition, and/or strength of the drug (Article 7 of BPOM Reg. 7/2026).
Core Criteria of Promotion and Advertising: Objective, Complete, Not Misleading
Both Promotion and Advertising must be objective (consistent with the latest approved labeling and not deviating from the drug’s approved efficacy and safety profile), complete (consistent with the information approved in the marketing authorization), and not misleading (honest, accurate, accountable, not creating a misleading impression, and not leading to irrational drug use or health risk) (Articles 3, 8(1), and 13(1) of BPOM Reg. 7/2026). Pharmaceutical industry businesses and PBFs must factor Promotion-related risk into the risk management embedded in their quality systems for good manufacturing and distribution practices, focusing on stock management, including estimated demand and disease prevalence, shelf life, supply chain integrity, and return or outright-purchase policies, in order to prevent misuse or distribution irregularities (Article 8(3) to (5) of BPOM Reg. 7/2026).
Promotion Operators and Sponsorship
Promotion activities are carried out by “Promotion Operators”, which include medical representatives, product specialists, or similar marketing personnel; sales staff of pharmaceutical industry players and/or PBFs; and other assigned parties (Article 10(1) to (3) of BPOM Reg. 7/2026). Further, the pharmaceutical industry, PBF, pharmaceutical service facility, electronic pharmacy system provider, and/or other facility is responsible for all statements and activities of its Promotion Operators, who must in turn have adequate qualifications (covering the promoted product, communication, marketing, promotion ethics, pharmacovigilance, and/or applicable laws and regulations) and must report safety-related information received to the relevant principal (Articles 10(4) and (5), and 11 of BPOM Reg. 7/2026). The relevant entities must also be responsible for training their Promotion Operators and must establish and implement operating procedures to supervise their Promotion activities (Article 11(4) and (5) of BPOM Reg. 7/2026). The pharmaceutical industry and PBF may sponsor medical and/or health personnel as a form of Promotion, subject to applicable laws and regulations (Article 12 of BPOM Reg. 7/2026).
Advertising Requirements: Language and Special Information
Advertising through information media must generally use Indonesian, save for limited exceptions for foreign or regional languages that are translated, commonly understood, or directed at an audience confirmed to understand that language (Article 14 of BPOM Reg. 7/2026). Accordingly, advertisements for certain categories of over-the-counter drugs, including cough/flu remedies, antiallergics, asthma medication, antacids, anthelmintics, topical antifungals, eye drops, mouthwash, sore throat remedies, bruise ointments, laxatives, motion sickness remedies, antimalarials, and antidiarrheals, must include mandatory disclosure statements specific to that drug category (e.g., drowsiness warnings for antihistamines, dosage warnings, or advice to consult a doctor if symptoms persist), as set out in Annex II of BPOM Reg. 7/2026, except where the advertisement is directed at medical and/or health personnel for hard drugs, narcotics, and/or psychotropics (Article 15 of BPOM Reg. 7/2026).
Advertising Media and Mandatory Contact Information
Drugs may be advertised through visual, audio, and/or audio-visual media, as detailed in Annex III, and this expressly includes social media (Article 16 (1) of BPOM Reg. 7/2026). Annex III further identifies, among others, newspapers, magazines, brochures, posters, billboards and static online/social-media displays as visual media; radio and online/social-media audio recordings as audio media; and television, cinemas, videotrons and online/social-media videos as audio-visual media. Social media may offer two-way communication features between the advertiser and the public, provided the information conveyed remains objective, complete, and not misleading, consistent with the approved advertisement design (Article 16 (4) of BPOM Reg. 7/2026). Visual media advertisements must generally display a public information service contact, except where the visual advertisement runs for less than six seconds, and that contact may not be used for further Advertising or Promotion purposes (Article 17 of BPOM Reg. 7/2026).
Advertising Approval Process
Non-prescription drugs advertised to the general public require BPOM approval before publication (Article 18 of BPOM Reg. 7/2026). Such approval shall be granted through the following steps:
- An applicant (being a pharmaceutical industry business holding marketing authorization for the drug to be advertised) must first register an account through BPOM’s official advertising approval portal, submitting its tax identification number, pharmaceutical industry business license, and a stamped letter designating an account controller, subject to verification within three days (Articles 19 and 20 of BPOM Reg. 7/2026). The account controller must be a representative of the pharmaceutical industry responsible for, or authorized to handle, the Advertising application process.
- Applications for advertisement approval are submitted electronically (or manually in the event of technical issues) together with the marketing authorization approval, approved label design, advertisement design (print-ads for visual media, scripts for audio media, and storyboards for audio-visual media), and any required translations (Articles 21, 22, and 24 of BPOM Reg. 7/2026). For online media, including social media, the advertisement design must also include the caption, description, and/or hashtags forming part of the relevant upload (Articles 21, 22, and 24 of BPOM Reg. 7/2026).
- Following document verification and payment of the applicable fee, BPOM evaluates applications within tiered timeframes depending on category: one day for “notification” category advertisements previously approved advertisements with certain changes that do not alter the meaning, including changes to publication media, shortening of claims or duration, and/or combining images or claims from several approved advertisements), ten days for “minor” category (new concepts using already-approved claims), and 25 days for “major” category (new concepts with potential for misinterpretation, or advertisements with material variations from a prior approval) (Articles 23 and 25 of BPOM Reg. 7/2026).
- The evaluation timeline uses a “clock on/clock off” mechanism, pausing when BPOM requests corrections or additional data (which the applicant may submit up to three times, each within 20 days) and resuming once the applicant responds (Article 26 of BPOM Reg. 7/2026). BPOM issues either an approval (per design) or a rejection; if rejected, the application is deemed void and fees already paid are non-refundable (Article 27 of BPOM Reg. 7/2026). The issuance of Advertising approvals is carried out through the online single submission system, which is electronically integrated with BPOM’s official Advertising approval service (Article 28 of BPOM Reg. 7/2026).
An advertisement approval remains valid for as long as the underlying marketing authorization remains valid and the advertisement continues to meet the applicable criteria and requirements (Article 29 of BPOM Reg. 7/2026). However, BPOM may re-evaluate an approved advertisement where new safety or quality data emerges, potentially resulting in a required correction or revocation of approval (Article 30 of BPOM Reg. 7/2026).
Certain categories of advertisements are exempt from prior approval, including advertisements showing only the trade name and manufacturer, only the approved packaging image, information identical to the approved labeling without added claims, price lists/catalogues, changes only to the cast, layout-only changes, internal pharmaceutical industry materials, and advertisements directed at medical and/or health personnel (which must bear the notation “Only for Medical Personnel” and/or “Only for Health Personnel”); these exemptions remain subject to the general objectivity, completeness, and non-misleading requirements (Article 31 of BPOM Reg. 7/2026).
Detailed Advertising Content Standards
Annex I of BPOM Reg. 7/2026 sets out detailed content requirements across four categories. Under the objectivity requirements, advertisements may not, among other restrictions, claim a drug is “safe”, “harmless”, or “free of side effects” without adequate qualification; may not use awards or as advertising content; may not suggest a drug confers energy, fitness, intelligence, stress relief, mood enhancement, or sexual performance benefits; may not imply preventive use outside the approved indication; and may not use superlative or hyperbolic claims beyond the approved indication. Advertisements also may not use information that is irrelevant to consumers, highlight a particular ingredient as an advantage, suggest that a multi-ingredient drug has indications beyond its approved claims, present a drug as resembling a herbal/traditional medicine, or use words suggesting an instant or rapid effect unless the drug in fact has a rapid effect.
Under the completeness requirements, advertisements must display active ingredient composition and strength (for visual media), approved indication, trade name, marketing authorization holder, marketing authorization number, advertisement approval number, public information contact, a mandatory caution notice (such as “Read the Instructions for Use, If Illness Persists Contact a Doctor”), and any special drug-category information, each displayed legibly in a contrasting ink color. Where an advertisement features more than one drug, it must also state the indication for each drug. The Annex also prescribes specific presentation requirements for the caution notice, including requirements concerning its size, contrast, placement, and duration depending on the advertising medium.
Under the non-misleading requirements, advertisements may not discourage medical consultation, encourage self-diagnosis of serious conditions, be endorsed by medical personnel, health authorities, religious figures, or public officials, use superlative language, promote side effects as a benefit, guarantee efficacy, or draw comparisons with other products except where beneficial, non-misleading, and not implying superiority. Advertisements are also prohibited from encouraging continued use through expressions such as “always” or “routinely”, using food-related claims such as “fresh”, “delicious” or “tasty”, exploiting superstition or public lack of knowledge, or misusing scientific terms, statistics, or graphs to create misleading or exaggerated impressions.
A further category of general restrictions prohibits advertisements that are indecent, target children without adult supervision, use testimonials or endorsements, run in immediate proximity to related public service announcements, or repeat identical content more than twice in succession, among other requirements (Article 13 (3) and Annex I of BPOM Reg. 7/2026). In particular, Annex I prohibits testimonials or endorsement concepts by medical personnel, health personnel, celebrities, or other professions encouraging the public to use the drug; advertisements from being placed together with or adjacent to related public service advertisements; and identical advertising material from being displayed consecutively or replayed more than twice. It also prohibits, among other matters, the use of settings associated with healthcare facilities, laboratories, schools, scientific meetings or religious activities where these may be misleading, discrimination, and the use of halal terminology as a principal message intended to influence a purchase decision.
Obligations for Industry Participants
The pharmaceutical industry, PBF, pharmaceutical service facilities, electronic pharmacy system providers, and other facilities must ensure Promotion complies with laws and regulations, and marketing authorization holders must guarantee that published Advertising meets the applicable criteria and requirements and remain responsible for advertisements they create even where published by a third party (Articles 32 and 33 of BPOM Reg. 7/2026). PBFs, pharmaceutical service facilities, electronic pharmacy system providers, and other facilities advertising non-prescription drugs to the general public must do so pursuant to cooperation with the marketing authorization holder, except for advertisements limited to packaging image, product name, active ingredient, strength, and indication as stated on the packaging (Article 34 of BPOM Reg. 7/2026).
Prohibited Conduct
BPOM Reg. 7/2026 prohibits, among other conduct: providing cash or in-kind bonuses or gifts, directly or indirectly, to the public, health personnel, or medical personnel (including their families and affiliates) in connection with product sales; prescribing arrangements or cooperation intended to boost sales of a particular drug; multi-level marketing schemes for drug sales; prize-linked promotions tied to packaging returns or quizzes; disguised promotion through clinical trials, epidemiological studies, or other research not conducted purely for scientific purposes; distribution of free drug samples to the public; bundled bonuses in the form of drugs or other pharmaceutical products; excessive discounts that could distort fair competition; and discounts structured as commissions (Articles 35 and 36 of BPOM Reg. 7/2026). Research activities used in connection with Promotion must be conducted only for scientific purposes and may not be designed to encourage prescription of the drug by medical personnel.
Further, pharmaceutical service facilities, electronic pharmacy system providers, and other facilities are prohibited from promoting prescription drugs altogether, and electronic pharmacy system providers may not display prescription drug product information, packaging, or names to the public in connection with advertising, promotion, or direct sale (Article 37 of BPOM Reg. 7/2026). Additionally, two-way social media communication features may not be used as a transaction channel for buying and selling drugs (Article 38 of BPOM Reg. 7/2026), and individuals are generally prohibited from conducting Promotion and/or Advertising (including publication), except where formally engaged by the pharmaceutical industry as an advertisement cast member (Article 39 of BPOM Reg. 7/2026).
Supervision and Administrative Sanctions
BPOM officers supervise Promotion activity and post-publication Advertising, and are empowered to collect data, information, or documents (including images, photos, and videos), inspect facilities related to Promotion and/or Advertising, and evaluate advertisements in circulation; violations of health professional codes of ethics are referred to the relevant professional disciplinary body (Articles 40 and 41 of BPOM Reg. 7/2026). Breach of specified provisions, including the core objectivity/completeness/non-misleading requirements, the risk management obligations, the prior-approval requirement, the prohibited bonus and marketing practices, and the prohibition on individual promotion, may be subject to administrative sanctions, ranging from a warning to temporary suspension of activities or revocation of the marketing authorization:
- warning;
- a strict warning; and
- temporary suspension of activities, revocation of the marketing authorization, and/or revocation of the Good Distribution Practice (CDOB) certificate (Article 42 of BPOM Reg. 7/2026).
Transitional Provisions
Advertisement approval applications submitted before BPOM Reg. 7/2026 took effect continue to be processed under the prior BPOM Regulation No. 2 of 2021. Approvals already issued under that prior regulation remain valid to the extent not inconsistent with BPOM Reg. 7/2026, and where inconsistent must be brought into conformity within 12 months of promulgation (Article 44 of BPOM Reg. 7/2026).
Concluding Remarks
BPOM Reg. 7/2026 sets out a more detailed regulatory framework for drug promotion and advertising in Indonesia. It responds to developments in health law, the shift to risk-based licensing in the drug and food subsector, and the growing use of digital and social media as an advertising channel. While the core objectivity, completeness, and non-misleading standards carry over from the predecessor regulation, the new regulation introduces materially more detailed content standards (particularly in Annex I), a formalized tiered and time-bound approval process with a clock on/clock off mechanism, express regulation of social media advertising and two-way communication features, and an expanded set of prohibited commercial practices targeting bonuses, discounts, and disguised promotion. It also sets more differentiated requirements based on drug classification and target audience, including specific rules for promotion to medical and health personnel, as well as rules on promotion operators, sponsorship, advertising media, mandatory information, and the validity and re-evaluation of advertising approvals.
Pharmaceutical industry players, wholesalers, pharmaceutical service facilities, and electronic pharmacy system providers should review their existing advertising materials, promotional practices, and vendor/agency arrangements against the new criteria, particularly the detailed Annex I content restrictions and the prohibitions on bonuses, discounts, and individual Promotion and/or Advertising, and bring any non-conforming advertisement approvals into compliance within the 12-month transition period. They should also check their internal advertising approval and monitoring processes against the prior-approval requirements, prescribed advertising language and mandatory information, audience restrictions, and the rules on digital and social media channels. Given the wider supervision powers and potential administrative sanctions, businesses should keep the documentation and controls needed to demonstrate compliance with the new requirements.
Disclaimer: The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their circumstances.
