New Regulation on Drugs Promotion and Advertising
The Indonesian Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan or “BPOM”) enacted BPOM Regulation No. 7 of 2026 dated April 29, 2026, on Drug Promotion and Advertising (“BPOM Reg 7/2026” or the “New Regulation”). The New Regulation replaces BPOM Regulation No. 2 of 2021 dated February 3, 2021, on Guidelines for Supervision of Drug Advertising (“BPOM Reg 2/2021”).
The New Regulation is enacted pursuant Law No. 17 of 2023 dated August 8, 2023, on Health (the “Health Law”) and its implementing regulation, Government Regulation No. 28 of 2024 dated July 26, 2024, on the Implementation of Health Law (“GR 28/2024”), together with Law No. 8 of 1999 dated April 20, 1999, on Consumer Protection.
The New Regulation introduces broader and more detailed rules on pharmaceutical promotion and advertising, particularly in relation to digital advertising, prescription drug promotion, supervision, and compliance obligations. Below are the key changes introduced under the New Regulation.
♦ Expanded Scope in New Regulation
The New Regulation expands several aspects previously regulated under BPOM Reg 2/2021, including the following:
- Expanded Scope of Regulated Parties
Under BPOM Reg 2/2021, promotional and/or advertising activities for drugs that have obtained marketing authorization may only be conducted by the pharmaceutical industries holding the relevant marketing authorization (izin edar or the “Permit”).Under the New Regulation, the scope of regulated parties has been expanded to include the following entities:
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- pharmaceutical industry;
- pharmaceutical wholesalers/distributors (Pedagang Besar Farmasi or a “PBF”);
- pharmaceutical service facilities, which include hospital pharmacy installations, clinic pharmacy installations, and pharmacies;
- pharmaceutical electronic system providers; and/or
- other entities.
All the above, collectively, the “Regulated Parties.”
Note that the Regulated Parties may only conduct the promotion and/or advertisement of drugs that have the Permit.
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- Risk Management in Promotional Activity
The New Regulation introduces risk management obligations, whereby the Regulated Parties are now required to assess and manage risks arising from promotional activities to prevent misuse and/or illegal drugs distribution. Such risk management includes stock management, including estimated demand and disease prevalence, shelf life, supply chain integrity, and return policies. - Sponsorship as Promotion
The New Regulation expressly recognizes sponsorship as a form of promotion, allowing pharmaceutical industries and a PBF to provide sponsorships to healthcare professionals in accordance with applicable laws and regulations.
♦ New Rules on Prescription Drug Promotion
The New Regulation provides more comprehensive provisions and restrictions on the promotion of prescription drugs. The New Regulation provides more detailed stipulation on the permitted promotional media by allowing promotional activities directed to healthcare professionals through restricted-access scientific forums and digital platforms, including e-detailing platforms, professional presentations, and scientific brochures, provided that:
- the access must be restricted exclusively to medical professionals and/or healthcare workers; and
- the promotional materials must be scientifically accountable and non-misleading.
Article 37 (1) of New Regulation stipulates that the promotion of prescription drugs is prohibited from being carried out by pharmaceutical service facilities, electronic pharmaceutical system providers, and other facilities.
Further, the New Regulation imposes stricter limitations regarding the display of prescription drugs on official websites of pharmaceutical industry marketing authorization holders as part of company profiles, limiting such display to product packaging, trade name, composition, and/or drug strength only.
♦ New Requirement on Digital Advertising of Drugs
Article 16(3) of BPOM Reg 7/2026 also introduces several provisions specifically addressing digital advertising practices, one of which relates to social media content requirements. Under this New Regulation, online advertisements, including social media advertisements, must include captions, descriptions, hashtags, or similar supporting text as an integral part of each publication.
In regard to the advertisement through audiovisual media, previously BPOM Reg 2/2021 required the storyboard submissions to consist of a maximum of 6 frames per page. In the New Regulation that technical restriction is removed, provided that the storyboard is submitted in a clear and readable resolution and includes descriptions, narratives, background texts, and/or background audio for each frame.
♦ Broader Exemption of Advertisement Approvals
The New Regulation significantly expands the criteria of advertisements exempted from a prior BPOM advertisement approval (persetujuan iklan) before publication. The Regulated Parties are also not required to submit an application for a BPOM approval if the advertisements meet the following criteria.
- Advertisements that only involve a change of advertisement talents from the previously approved advertisement;
- Advertisements that only involve changes to the design, orientation, or layout of a previously approved advertisement, provided that such changes do not alter the meaning of the advertisement;
- Advertisements intended solely for internal pharmaceutical industry purposes; and/or
- Advertisements intended for medical professionals and/or healthcare professionals, which must include statements such as the following:
- “For Medical Professional Use Only” or “Hanya untuk Tenaga Medis;” and/or;
- “For Healthcare Professional Use Only” or “Hanya untuk Tenaga Kesehatan.”;
♦ Changes to Advertisement Evaluation and Supervision
Under BPOM Reg 2/2021, advertisements categorized as notification-category advertisements could be processed through a self-assessment mechanism (i.e., independent evaluation by the applicant without BPOM review, processed automatically via the SIAPIK system). The New Regulation changes this approach by requiring an evaluation by BPOM officials even for notification-category advertisements.
Under Article 25(2) of the New Regulation, the evaluation timelines by BPOM officials are as follows:
- 1 working day for notification advertisements;
- 10 working days for minor advertisements; and
- 25 working days for major advertisements.
♦ Administrative Sanctions
Compared to BPOM Reg 2/2021, the New Regulation removes the administrative sanction in the form of suspension of a Permit and introduces the revocation of Good Drug Distribution Practice (Cara Distribusi Obat yang Baik or “CDOB”) certification.
Accordingly, administrative sanctions under the New Regulation may include the following:
- warnings;
- severe warnings (peringatan keras);
- temporary suspension of activities;
- revocation of marketing authorization; and/or
- revocation of CDOB certification.
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Azzahra Saffanisa Sudiardiputri (asudiardiputri@aksetlaw.com) or Shafa Femalea Sekar Nuswantari (snuswantari@aksetlaw.com) for further information.
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