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May 29, 2026

Indonesia Expands Rules on Drug Promotion and Advertising

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Indonesia’s Food and Drug Authority (BPOM) has issued Regulation No. 7 of 2026 on Drug Promotion and Advertising, establishing an updated framework for promotional activities involving medicinal products in Indonesia. The regulation took effect on April 16, 2026, and supersedes BPOM Regulation No. 2 of 2021 on Drug Advertising Supervision.

The new regulation maintains general principles for advertising content, including requirements that advertisements be objective, complete, and not misleading, as further detailed in its annex. It also confirms that advertisements for nonprescription drugs directed to the public must obtain prior approval from BPOM before publication and must be in Bahasa Indonesia.

The regulation provides a more comprehensive framework governing how drug promotion is conducted, introducing several notable additions and changes, as described below.

Procedure and Requirements for Drug Advertisement Approval

To apply for a drug advertisement approval, applicants must create an online account through the dedicated portal SIAPIK. Advertisement approval is available only for registered drugs; unregistered drugs are not eligible for advertisement approval with BPOM.

The application must include the advertisement design, along with a translation if the design contains any wording in a foreign language. The submission format varies by media type, requiring, for example, copies in the form of print advertisements for visual media, scripts for audio media, and storyboards for audiovisual media. For online media—including social media—submissions should include any captions, descriptions, and hashtags that form an integral part of the advertising material.

The approval timeline takes approximately 3–4 months, as BPOM will generally request additional information or revisions during the verification and evaluation process. Applicants have 20 days to submit any such requested documents.

BPOM may also conduct a reevaluation of advertisements that have already received approval, based on monitoring results or new information regarding the safety and quality of the advertised drug. This could result in BPOM issuing a correction or revoking the initial approval.

Expanded Scope: From Advertising to Promotion

One of the key developments under the new regulation is its expanded scope. BPOM Regulation No. 2 of 2021 focused primarily on drug advertising. The new regulation covers drug promotion as a whole, with advertising treated as one form of promotional activity.

The regulation defines promotion as an activity in the field of marketing—including the provision of information or persuasion regarding drugs—carried out by pharmaceutical companies, pharmaceutical wholesalers, pharmaceutical service facilities, electronic pharmaceutical system providers, and/or other facilities authorized to dispense drugs, with the objective of increasing prescription, distribution, sales, or use of drugs. This broader scope means that activities beyond traditional advertisements may now fall within regulatory oversight, requiring companies to take a closer look at their overall promotional approach.

Expansion and Regulation of Parties Allowed to Promote Drugs

The regulation also broadens the range of entities allowed to conduct drug promotion. Promotion is no longer limited to pharmaceutical companies holding marketing authorization; it now includes pharmaceutical wholesalers (PBFs), pharmacy service facilities, electronic pharmaceutical system providers, and other relevant facilities.

is expressly recognized as a form of promotional activity. Pharmaceutical companies and pharmaceutical wholesalers are permitted to provide sponsorship to medical or healthcare professionals if it is carried out in accordance with applicable laws and regulations.

All promotional activities must be limited to products with valid marketing authorization and carried out in accordance with the guidelines provided in annexes to the regulation.

Individuals involved in drug promotion, including medical representatives and sales personnel, must have sufficient knowledge of the products being promoted, along with competency in communication, marketing, ethical aspects of promotion, pharmacovigilance, and applicable laws and regulations. They are also required to communicate information accurately, completely, and responsibly, and to report any safety-related information obtained from the public or healthcare professionals to the relevant entity.

Categorization of Drugs in Promotion Activities

The regulation introduces a clearer distinction between prescription drugs and nonprescription drugs. Promotion of prescription drugs—including potent, narcotic, and psychotropic drugs—is restricted to scientific media aimed at healthcare professionals, while nonprescription drugs (OTC and limited-OTC drugs) may be promoted to the public, subject to regulatory conditions.

Although prescription drugs cannot be advertised to the public, the regulation permits their limited display on official company websites of the relevant marketing authorization holders, restricted to basic product information such as product name, packaging, composition, and strength.

Inclusion of Electronic Pharmaceutical Systems

Electronic pharmaceutical system providers are expressly identified as entities that may carry out promotion and advertising of nonprescription drugs, provided such activities relate only to products with valid marketing authorization. Providers may also act as promotion organizers, either independently or on behalf of other stakeholders, such as pharmaceutical companies or distributors. This suggests that digital platforms are no longer considered merely intermediaries but may bear direct regulatory responsibility for promotional activities conducted through their systems.

Introduction of Risk Management in Promotion

The regulation also requires incorporation of risk management considerations into promotional activities. Pharmaceutical companies and pharmaceutical wholesalers, as part of their quality systems under Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) standards, are required to account for risks arising from promotional activities in order to prevent drug misuse or irregularities in drug distribution. This must be reflected in stock management, demand and disease prevalence estimation, shelf life, supply chain integrity, and return or purchasing policies.

Expanded Restrictions on Promotional Practices

The regulation introduces a detailed list of prohibited promotional activities, including:

  • Collusion in prescribing practices to increase sales,
  • Use of multilevel marketing schemes,
  • Promotional incentives such as rewards or quizzes,
  • Disguised promotion through research or studies,
  • Distribution of free samples to the public, and
  • Excessive discounting that may create unfair competition.

Only companies—not individuals—are allowed to initiate promotional activities and advertisements, including publications. An exception is made for individuals acting as advertising talent who have been formally appointed by pharmaceutical companies, ensuring that promotional activities remain under the control and responsibility of authorized entities. Furthermore, promotional activities must not use the concept of endorsements or recommendations from medical professionals, healthcare personnel, celebrities, or other professions that encourage the public to use the drugs.

Advertising Media

The regulation broadens and clarifies the range of media permitted for drug advertising. Drugs may now be advertised through visual, audio, and audiovisual media, explicitly including social media platforms. The regulation permits two-way communication features—such as comments and chats—between advertisers and the public on social media, provided the information remains objective, complete, not misleading, and consistent with approved advertisement content. However, such interactive features may not be used to facilitate sales transactions.

Practical Considerations

While BPOM Regulation No. 7 of 2026 introduces clearer guidance and broader coverage, its application may depend on specific factual circumstances, particularly regarding the categorization of promotional activities, digital communication strategies, and the involvement of multiple parties in distribution and promotion. These aspects may require careful interpretation on a case-by-case basis, depending on how the activities are structured.

Given the scope of the changes introduced, companies will likely need to review their existing promotional practices and assess potential compliance considerations.

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