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HONG KONG DRUG LICENSING

How are medicine advertisements regulated, and what should we as licence holders be aware of?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q368 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Hong Kong strictly regulates pharmaceutical advertising to prevent the public from being misled and to ensure that information is accurate. The main regulatory requirements include: 1. It is prohibited to advertise to the public medicines for treating diseases listed in Schedule 1 to the Undesirable Medical Advertisements Ordinance, such as cancer and diabetes. 2. It is prohibited to advertise prescription medicines (Part I poisons) to the public. 3. All pharmaceutical advertisements must be truthful and accurate, and must not contain false, exaggerated or misleading claims. 4. Advertisements must not imply that a medicine can “cure” a condition or is “100% effective”. As a licence holder, you must carefully review the content of any advertisement—including those on television, in newspapers, on websites and on social media—and ensure that it fully complies with the regulations before planning to publish it. Although restrictions on OTC medicine advertising are fewer, it should still be approached responsibly, with balanced information and a recommendation that consumers consult a healthcare professional before use.

📘 Regulatory basis

The principal regulatory legislation is the Undesirable Medical Advertisements Ordinance (Cap. 231). The Pharmacy and Poisons Ordinance (Cap. 138) also contains requirements concerning the labelling of medicines and promotional materials.

📗 Drew Tang's recommendations

We recommend that clients establish an internal advertising review process requiring all external promotional materials to be reviewed and approved by the compliance or regulatory affairs department. Advertising should primarily provide information rather than over-market products. Any cited data or research findings must be verifiable. If you are unsure whether a claim is compliant, the safest course is to consult a legal adviser or a professional organisation such as Rengangyongsheng (Hong Kong) Limited.

📕 Risk notice

The consequences of publishing unlawful medicine advertisements are serious. Once the Department of Health discovers them, it will immediately require publication to cease and may prosecute the licence holder, the advertiser and the media. Upon conviction, substantial fines and imprisonment may be imposed. In addition, misleading advertisements can seriously damage the company’s public image and brand reputation, making them not worth the risk.

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