Pharmaceutical marketing plays an important role in the healthcare ecosystem because it may influence prescribing decisions, patient expectations, and the public’s understanding of pharmaceutical products.[1] For this reason, promotional claims that are inaccurate, incomplete, or misleading may create not only commercial exposure, but also public health and regulatory compliance risks.

The issuance of the Drugs and Foods Control Authority (Badan Pengawas Obat dan Makanan or (“BPOM”) Regulation No. 7 of 2026 on Promotion and Advertising of Drugs (“BPOM Regulation 7/2026”) reflects Indonesia’s continued shift toward a lifecycle compliance approach, where regulatory oversight extends beyond product approval to post-market promotional activities. While Marketing Authorisation (Izin Edar or “MA”) remains a key regulatory milestone, companies’ obligations continue after a product enters the market, particularly in relation to how the product is promoted and communicated.

In this context, this article focuses primarily on the promotion-related aspects of BPOM Regulation 7/2026, as this represents the key regulatory development from the previous framework under BPOM Regulation No. 2 of 2021 on the Guidelines for the Supervision of Drugs Advertising, which focused on medicine advertising.

Expanded Regulatory Oversight Under BPOM Regulation 7/2026

This expanded framework is reflected in the Regulation’s distinction between promotion and advertising.

Previously, BPOM Regulation No. 2 of 2021 primarily regulated medicine advertisements, including advertising content, approval procedures, and dissemination. BPOM Regulation 7/2026 now expressly distinguishes between promotion (promosi) and advertising (iklan), thereby bringing a wider range of pharmaceutical marketing activities within BPOM’s oversight. Below are the definitions under BPOM Regulation 7/2026:

This distinction means that activities previously not considered advertisements may now fall within BPOM’s promotional oversight. Pharmaceutical companies should therefore assess not only public-facing advertisements, but also healthcare professional communications, promotional events, digital campaigns, and other product-related activities.

BPOM Regulation 7/2026 also introduces different requirements depending on the medicine classification. Prescription medicines may only be promoted to healthcare professionals through scientific channels, while non-prescription medicines may be promoted to the public subject to applicable advertising requirements.

The regulation further expands compliance obligations beyond pharmaceutical manufacturers to include Pharmaceutical Wholesalers (Pedagang Besar Farmasi or “PBF”), pharmaceutical service facilities, Electronic Pharmaceutical System Providers (Penyelenggara Sistem Elektronik Farmasi or PSEF), and other authorised parties involved in pharmaceutical promotion.

In addition, pharmaceutical manufacturers and PBFs are required to incorporate promotional activities into their quality risk management systems. Companies must establish appropriate controls over promotional personnel, including qualification standards, training programs, supervision procedures, and reporting obligations for medicine safety information obtained during promotional activities.

The regulation also introduces clearer restrictions on promotional practices, including sales-linked incentives, free medicine schemes, excessive discounts, commission-based arrangements, multi-level marketing (MLM), disguised promotions, sales-driven prescribing arrangements, and distribution of medicine samples to the public.

Overall, BPOM Regulation 7/2026 reflects a shift in Indonesia’s pharmaceutical regulatory approach. Promotional activities are no longer viewed solely as marketing initiatives, but as part of broader compliance, risk management, and corporate governance frameworks throughout the medicine lifecycle.

Digital Promotion: An Emerging Compliance Risk

Digital marketing has expanded the ways pharmaceutical companies communicate with healthcare professionals and the public. However, the accessibility and rapid dissemination of online content creates additional compliance risks, as promotional materials may be widely shared and remain available beyond their initial publication.

BPOM Regulation 7/2026 expressly recognises digital promotional materials. For online advertisements, elements such as captions, descriptions, hashtags, and other digital components form part of the promotional content and should be considered in the review process.

This is particularly relevant for public accessibility. Pharmaceutical service facilities and PSEF are prohibited from promoting prescription medicines or displaying prescription medicine information that is directly accessible to the general public. In addition, interactive features on social media platforms may not be used to facilitate medicine sales transactions.

Where companies engage advertising agencies, digital marketing partners, KOLs, influencers, or other third-party providers, such arrangements do not transfer regulatory responsibility away from the MA holder. Companies should therefore implement appropriate contractual arrangements, internal approval processes, training, and monitoring mechanisms to manage third-party promotional risks.

Non-Compliance and Ongoing Risk Monitoring

Non-compliance with BPOM Regulation 7/2026, including violations relating to misleading promotional content, non-compliant promotional activities, inadequate oversight of promotional personnel, digital promotion requirements, and prohibited promotional practices, may result in administrative sanctions. Such sanctions may include warnings, temporary suspension of activities, revocation of Marketing Authorisation, and/or revocation of Good Distribution Practices (Cara Distribusi Obat yang Baik or “CDOB”) certification, depending on the nature and severity of the violation.

Accordingly, for MA holders, this reinforces the need to ensure that promotional communications remain accurate, balanced, scientifically supported, and consistent with approved product information throughout the product lifecycle.

Transitional Period

Although the regulation was promulgated on 29 April 2026, it provides transitional arrangements for advertisements approved under the previous framework. Existing advertisement approvals issued under BPOM Regulation No. 2 of 2021 remain valid provided they are not inconsistent with the new regulation. Where inconsistencies exist, the approved advertisements must be aligned with BPOM Regulation 7/2026 within 12 months from its promulgation.

Practical Implications for Pharmaceutical Companies

With the transition period running until April 2027, pharmaceutical businesses should use this period to strengthen their promotional compliance framework. Key measures may include:

• Reviewing existing promotional materials and communications to ensure that claims remain accurate, supportable, and consistent with approved product information.
• Establishing clear internal review and approval processes involving relevant functions, including regulatory, medical, legal, and quality teams.
• Strengthening governance over digital promotional activities and third-party engagements, including agencies, healthcare professionals, and other external collaborators.
• Providing appropriate training and maintaining supporting documentation to demonstrate compliance with applicable promotional requirements.

Conclusion

BPOM Regulation 7/2026 reflects a shift in pharmaceutical marketing compliance, which is no longer limited to advertisement approval but extends to broader governance over promotional activities throughout the product lifecycle.

As promotional activities become subject to more detailed regulatory oversight, pharmaceutical companies should embed promotional compliance within their internal controls, approval workflows, training programs, and third-party oversight mechanisms.

By integrating regulatory, medical, legal, quality, and commercial considerations into promotional decision-making, companies can better manage compliance risks, maintain responsible promotional practices, and support sustainable market access in Indonesia’s evolving pharmaceutical landscape.

[1] For this article, the term “medicines” is used interchangeably with “drugs” for general reference.