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​ 

June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological
Read More
June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements
Read More
June 17, 2026
Thailand’s new labeling requirements for medical devices, which include for the first time a unique device identification (UDI) requirement for software as a medical device (SaMD), take effect on June 20, 2026. The Notification of the Ministry of Public Health regarding Criteria, Methods, and Conditions on Labeling and Instructions for Use for Medical Devices 2025, which replaces a similar notification from 2020, was published in the Government Gazette on December 22, 2025. To ensure clarity, modernity, and patient safety, the regulation requires domestic manufacturers and importers to provide labels and instructions for use (IFU) that are clearly legible, complete, and free of false or misleading claims. It also permits IFU to be provided in electronic format, such as via QR codes, websites, or other digital channels—directly relevant to SaMD, where physical labels are impractical and electronic presentation is the natural medium. The notification distinguishes two categories for labeling language. Home-use medical devices (for lay users outside healthcare facilities) must have labels and IFU in Thai. Professional-use medical devices may display labels and documentation in either Thai or English. This distinction is significant for SaMD developers: software intended for clinical professionals may use English-language interfaces and IFU, while consumer-facing health applications must provide Thai-language content. Labeling and UDI Requirements Labels and IFU must include, at a minimum: Product name and intended purpose Quantity or volume Name and address of domestic manufacturer or importer Thai FDA approval number Lot, version, or serial number Manufacturing date and expiry date For SaMD, the version number requirement is particularly relevant. The regulation also mandates display of a UDI code for SaMD in risk category 2 (moderate-risk), category 3 (moderate- to high-risk), and category 4 (high-risk), according to Thailand’s medical device risk classification system (which complies with the ASEAN Medical Device Directive and the EU
Read More
June 5, 2026
On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.
Read More