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​ 

March 30, 2026
In response to an emerging crisis on food safety, the government of Vietnam promulgated Decree No. 46/2026/ND-CP (Decree 46) on January 26, 2026, and Resolution No. 66.13/2026/NQ-CP (Resolution 66.13) on January 27, 2026, setting out a number of substantive changes to the procedure and strict requirements for the declaration, registration, and importation of food products. Both instruments took effect upon issuance. However, shortly after they entered into force, food businesses encountered significant implementation challenges, particularly with respect to state inspection procedures at the customs clearance stage for imported products. In response, the government issued Resolution No. 09/2026/NQ-CP (Resolution 09) on February 4, 2026, temporarily suspending Decree 46 and Resolution 66.13 until a new effective date of April 16, 2026. Continued Suspension of Implementation of Decree 46 and Resolution 66.13 After considering feedback gathered by the Ministry of Health from food businesses and other stakeholders during the suspension period, the Vietnam Government Office issued a notice on March 20, 2026, agreeing to extend the suspension until the issuance of an amended Law on Food Safety and its guiding decree. Following this notice, on March 22, 2026, the Ministry of Health prepared a draft resolution to implement the notice and replace Resolution 09. Under the draft resolution, the effectiveness of Decree 46 and Resolution No. 66.13 would continue to be suspended until the amended Law on Food Safety takes effect, except for the provisions under Resolution 66.13 allowing flexibility in documents evidencing product efficacy, which would take effect on April 16, 2026, and remain effective until the Law on Food Safety is replaced (but not later than February 28, 2027). Accordingly, for products subject to the registration declaration procedure, such as health supplements, efficacy may be substantiated by either (i) scientific evidence supporting the declared function and effects of the product
February 26, 2026
Laos’ Food and Drug Department (FDD) has been using a new online registration system for drugs since the beginning of the year. The system, which was implemented following the November 2025 issuance of Notice No. 5960/FDD, became the official pathway for submissions on January 1, 2026. Since that date, paper-based registrations have no longer been accepted. This marks a significant advancement in the digitalization of regulatory processes in Laos. As the online system is now the exclusive platform for registration, renewal, and amendments, companies that have not yet aligned their processes to the new system should act promptly to ensure a smooth transition. To assist with this, the FDD will conduct periodic training sessions on the use of the online registration system, which will be delivered either in person or remotely, depending on operator demand. To start using the system, drug and medical device manufacturers, as well as import-export companies, that have not yet registered must submit a formal request identifying the authorized personnel who will access the platform, after which they will be issued user accounts and access codes. Each request must be accompanied by the company’s enterprise registration certificate (incorporation certificate), a copy of the identity card or passport of each designated user, and a scanned copy of their signature. There is no restriction on the number of users per company, allowing flexibility to meet operational needs. Companies that already hold accounts and access codes from the trial phase may continue using them and may apply for additional accounts if needed. Additional Requirements The new system also introduces a standardized format for drug registration numbers. For example, an import drug registration number such as 06 I 4040/15 will be changed to 06-IM-04040-15, and a domestic drug registration number such as 06 L 4040/15 will be changed to
January 21, 2026
Spurred by global geopolitics and Canada’s Indo-Pacific Strategy, which aims to forge deeper ties with ASEAN, Canadian companies have been showing growing interest in Thailand and Southeast Asia in recent years. To understand the opportunities offered by the region, we sat down with Andrew Stoutley, a Toronto native and the chief operating officer of Tilleke & Gibbins, a leading Southeast Asian regional law firm with over 130 years of history in Thailand. Q: Why are Canadian companies looking at Thailand and Southeast Asia right now? A: Two reasons stand out. First, diversification has moved up the agenda. Many Canadian companies want options outside North America due to tariff volatility and policy uncertainty in the United States, as well as questions around the next Canada–United States–Mexico Agreement mandatory joint review. At the same time, the shift of global production from China to Southeast Asia is accelerating, driven by rising costs, geopolitics, and the need to avoid overreliance on a single market. As a result, Canadian companies are looking for a second production base or a regional hub, and Thailand and its neighbors are natural choices given their manufacturing depth, location, and established supply chains. Second, Canada’s own efforts in the region are gaining traction. The Indo-Pacific Strategy has led to more on-the-ground support, including larger trade missions, upgraded diplomatic posts, and new financing options. Export Development Canada (EDC) now has a presence in Bangkok, giving Canadian companies a direct line to financing and insurance in Thailand. There’s also steady progress on trade frameworks like the recently signed Canada–Indonesia Comprehensive Economic Partnership Agreement (which will come into effect pending domestic procedures), ongoing negotiations of a Canada–ASEAN FTA, and the exciting announcement about the launch of negotiations of a Canada–Thailand FTA. Together, these developments have the potential to make it much easier
January 8, 2026
Thailand’s approach to cannabis regulation has moved quickly from broad access to a medical, prescription‑only system. The latest government regulation classifies the cannabis flower as a controlled herb under the Thai Traditional Medicine Wisdom Act. The latest rules ban advertising and recreational sales, allow sales only to patients with prescriptions (up to 30 days), and require flowers to come from GACP‑certified (Good Agricultural and Collection Practices) farms. More importantly, cannabis dispensaries can only sell to patients presenting valid prescriptions issued by one of seven professions—medical doctors, Thai traditional practitioners, applied Thai traditional practitioners, traditional Chinese medicine practitioners, pharmacists, dentists, and folk healers—consistent with approved clinical indications. Noncompliance risks license suspension or revocation, and criminal penalties of up to one year’s imprisonment or a THB 20,000 fine. The dispensary‑only model that proliferated in Thailand in recent years is expected to end soon, as the rules will push all cannabis dispensaries into medical settings or retail pharmacies. Dispensaries must convert into medical establishments—clinics, pharmacies, or traditional pharmacies—complete with on‑site licensed practitioners as well as budtenders; strong controls for storage, hygiene, odor, and smoke; and facilities for record-keeping. All flowers dispensed or exported must come from GACP‑certified farms. If the government ends dispensaries outright and forces a conversion to clinics or pharmacies, compensation will not be automatic at the outset. As a result, business operators should plan for compliance and repurposing under the Medical Facilities Act, Modern Drug Act, and Herbal Product Act, which regulate medical clinics, modern pharmacies, and traditional medicine pharmacies, respectively. The table below summarizes the required licenses for clinics, pharmacies, and traditional medicine pharmacies selling cannabis flowers in Thailand. Aside from the specific listed licenses, all three types of establishments must also obtain a license to sell a controlled herb (cannabis flowers) from the Department of Thai Traditional