You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

May 29, 2026

Indonesia Expands Rules on Drug Promotion and Advertising

Subscribe to Updates

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.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

May 28, 2025
Thailand’s Food and Drug Administration (FDA) has launched a strategic collaboration with leading e-commerce platforms Lazada and Shopee to strengthen regulatory oversight of health-related products sold online. This partnership is part of a broader initiative to enhance consumer protection, enforce compliance with Thai health regulations, and foster a safer digital marketplace for health products. As part of this initiative, the Thai FDA is urging all sellers—particularly cross-border vendors—to secure proper FDA registration for their products before market entry. The objective is to ensure that only legally authorized, safe, and quality-assured healthcare products are available to Thai consumers. In pursuit of this goal, the FDA has been working closely with Lazada and Shopee to implement proactive surveillance mechanisms aimed at identifying and removing noncompliant, substandard, or unregistered products. This collaboration has already yielded measurable results. Between September 2023 and 2024, Lazada supported regulatory enforcement by removing 9,454 noncompliant listings and delisting 30 vendors. In addition, 134 sellers were subjected to legal proceedings for regulatory violations. Shopee has taken a similarly rigorous stance, committing to the immediate removal of products found to be in breach of FDA regulations. The platform has also provided educational materials for merchants and implemented consumer complaint mechanisms to enhance accountability. Looking ahead, the Thai FDA plans to roll out a data integration system utilizing API technology, enabling seamless and secure exchange of regulatory data between the agency and e-commerce platforms. This system will be supported by comprehensive training for both Thai FDA officials and e-commerce staff, with a particular focus on the use of the Thai government’s Law Enforcement Request Portal, a secure communication channel for coordinating enforcement actions between government agencies and platform operators. Additionally, a joint product inspection framework is currently under development in partnership with Lazada and Shopee. This framework will incorporate strict
Read More
May 27, 2025
On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards. Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV). For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12. Drug registration The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms
Read More
May 15, 2025
Vietnam’s Ministry of Health (MOH) has published for public consultation a draft amendment of the Law on Donation, Recovery, and Transplantation of Human Tissues and Organs and Donation and Retrieval of Cadavers, a law which has been in effect since 2007. Among its changes, the draft amendment notably includes new provisions on stem cells, a hot-button topic with social, legal, and ethical ramifications extending beyond the medical field. There are currently no specific regulations on stem cells under Vietnamese law—only the MOH’s technical guidance—leaving many controversial issues unsettled. Key points related to stem cells that may impact the activities of researchers and institutions in Vietnam and abroad are highlighted below. Requirements for Stem Cells Under the draft amendment, stem cells are defined as cells naturally occurring in the body, having the ability to divide and differentiate into various types of cells. The draft amendment outlines conditions for stem cell donation, establishes requirements for medical facilities authorized to receive stem cell donations, and specifies the rights of stem cell donors. Under the draft amendment, it is prohibited to receive, screen, or produce stem cells at facilities that do not satisfy conditions. Establishment of Private Stem Cell Banks In addition to state-owned stem cell banks, the draft amendment also addresses independent stem cell banks established by private investors. In general, the stem cell banks (whether public or private) must obtain an operation license by meeting various conditions on personnel, equipment, facilities, and management systems to be further guided by the government. Notably, stem cell banks will have the right to cooperate with foreign entities in exchanging stem cells for treatment, education, and research purposes. Prohibition on Creating Embryos for Stem Cell Research or Therapy Considering the ethical concerns over the use and destruction of embryos, the draft amendment expressly prohibits the
Read More
May 2, 2025
Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.
Read More