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

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 INSIGHTS​ 

July 14, 2025
Life sciences specialists from Tilleke & Gibbins have updated the firm’s guide to pharmaceutical data exclusivity regulations and practices in Southeast Asia. This guide contains quick-reference information on the availability of data exclusivity protections and limitations in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support
July 8, 2025
On July 3, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 34/2025/TT-BYT amending some articles of Circular No. 06/2011/TT-BYT on the management of cosmetics products (Circular 34), which provides the current regulations on the product notification process for cosmetics (cosmetic notification). Circular 34 will come into effect on August 18, 2025. Changes to Cosmetic Notification Some of the key stipulations of Circular 34 are outlined below. Addition of submission route for notification Circular 34 officially adds online submission via the National Public Service Portal as an accepted type of cosmetic notification, in addition to direct submission and submission via post. Clearer regulations on preparing cosmetic notification form Circular 34 provides clarification on the signing requirements for cosmetic notification forms. For online submissions, both e-signatures and digital signatures are accepted. For offline submissions, the circular explicitly states that stamped/generated signatures are not acceptable. There are no substantive changes to existing requirements regarding grouping of products in a single declaration, ingredient listing, or language used in the notification form. Circular 34 only introduces formatting adjustments to these provisions. Updated administrative procedures Circular 34 updates requirements on digital procedures and authentication for online submission with references to new government decrees. In addition, processing timelines for cosmetic notification are further clarified, in particular, five working days for feedback on incomplete dossiers and five working days for approval after receiving complete supplemental dossiers. Revised requirements for import of samples for testing and research An updated Appendix 14-MP form is introduced with Circular 34, in which the receiving authority is updated from the Drug Administration of Vietnam to the specialized health agency under the provincial People’s Committee. Both online and direct submission of the request are allowed. The approval timeline is three working days from the date of reviewing the request. Transition clause Notifications
July 8, 2025
On June 29, 2025, the government of Vietnam issued Decree No. 163/2025/ND-CP providing detailed guidance on the implementation of the amended Law on Pharmacy (Decree 163). Decree 163, like the amended Law on Pharmacy, took effect on July 1, 2025, officially replacing Decree No. 54/2017/ND-CP (Decree 54). The new decree introduces comprehensive regulations across key areas of pharmaceutical management such as pharmacy practice certificates, certificates of eligibility for pharmaceutical business, import and export of drugs and drug materials, GMP inspection of foreign manufacturers, drug and drug material recall, certificates of drug advertising content, and drug price management. Key Changes in Decree 163 Some outstanding changes and additions in Decree 163 are presented below. Destruction of Specially Controlled Drugs It is no longer required to obtain approval from the competent authority before the destruction of narcotic, psychotropic, and precursor drugs, and pharmaceutical ingredients that are narcotic or psychotropic substances, or precursors used in drugs. Instead, notification must be provided at least seven working days in advance, including the proposed destruction date and a detailed list of items to be destroyed. E-commerce in Pharmaceuticals Pharmaceutical businesses operating via e-commerce platforms must publicly disclose the following information to ensure transparency and consumer safety: (i) certificate of eligibility for pharmaceutical business, (ii) pharmacy practice certificate of the person responsible for pharmaceutical expertise, and (iii) drug information. Shelf-Life Requirements for Imported Products For drugs and ingredients with a total shelf life of nine months or less, at least one-third of the shelf life must remain at the time of customs clearance. Drugs with a shelf life of 30 days or less must still be within their shelf life at the time of clearance. Control of Imported Products Drugs subject to import control include all drugs with marketing authorization (MA), except for (i) drugs that
May 28, 2025
Tilleke & Gibbins attorneys in Vietnam have contributed the 2025 edition of Doing Business in Vietnam, a comprehensive Q&A-style resource from Thomson Reuters Practical Law that provides essential insights for companies navigating business operations in Vietnam. The guide presents a detailed overview of the country’s legal framework and regulatory environment, reflecting recent updates in Vietnamese legislation and practice. This annually updated guide offers key information on the following areas: Legal system: Structure of the Vietnamese judiciary and the role of codified law. Foreign investment: Conditions for market access, licensing requirements, foreign ownership restrictions, and investment incentives. Business vehicles: Formation and operation of legal entities, including limited liability companies, joint-stock companies, and representative offices. Employment: Employment contracts, social insurance, labor rights, and procedures for hiring foreign nationals. Tax: Overview of corporate income tax, personal income tax, value-added tax, and other tax obligations. Intellectual property: Procedures for protecting and enforcing patents, trademarks, copyrights, and other IP rights. Data protection: Compliance requirements under Vietnam’s data privacy laws, including the Personal Data Protection Decree. Competition law: Antitrust rules and regulatory oversight under the Law on Competition. Anti-bribery and corruption: Legal framework and enforcement practices aimed at curbing corrupt activities. E-commerce and digital business: Regulations governing online platforms, digital content, and cross-border services. Marketing and advertising: Laws and guidelines on advertising standards and consumer protection. Product regulation and liability: Safety requirements, product liability issues, and roles of relevant authorities. Doing Business in Vietnam is part of Practical Law’s global series of legal guides designed to support international practitioners and businesses. To access the most recent edition of the Vietnam guide, visit the Practical Law website and sign up for a free trial.