What Changed
- DH and Police seized over 1,600 vials of unregistered injectable products and arrested three individuals in September 2026 during WT1 investigation.
- Between January 2023 and August 2026, DH conducted 36,200 inspections, handled 105 convictions under Cap. 138, and issued over 1,600 warning letters under Cap. 231.
- The Hong Kong SAR Government announced plans to establish the Hong Kong Centre for Medical Products Regulation within 2026.
Background
In a Legislative Council written reply on October 7, 2026, the Secretary for Health of Hong Kong SAR, Professor Lo Chung-mau, detailed the Government's regulatory enforcement against the illegal sale, possession, and advertisement of unregistered pharmaceutical products. The response addressed a question by Professor the Hon Chan Wing-kwong following law enforcement actions against premises claiming to offer "Wilms' tumour 1" (WT1), an unregistered product promoted as a cancer prevention vaccine.
In July 2026, the Department of Health (DH) initiated an investigation upon receiving intelligence regarding WT1 claims. Following unannounced inspections, the DH and the Hong Kong Police Force conducted joint raids in early September 2026 across four premises. Authorities seized over 1,600 vials of suspected unregistered injectable pharmaceutical products. Three individuals, including a registered medical practitioner, were arrested for suspected illegal possession of unregistered pharmaceutical products and Part 1 poisons. The DH confirmed that WT1 is not registered in Hong Kong SAR and has no registration history with drug regulatory authorities in Mainland China or any overseas jurisdiction.
The DH referred the involved registered doctor and nurse to the Medical Council of Hong Kong and the Nursing Council of Hong Kong for professional follow-up. Furthermore, because related advertisements appeared on social media platforms in Mainland China, the DH notified Mainland law enforcement authorities, while alerting Hong Kong Customs to track potential illicit importation. Between January 2023 and August 2026, the DH Drug Office conducted approximately 36,200 regulatory inspections, leading to 105 conviction cases for selling or possessing unregistered medicines, with maximum penalties reaching 10 months' imprisonment or a fine of $242,000.
What the Rules Require
The Hong Kong SAR legal framework imposes strict requirements on pharmaceutical products and medical claims:
1. Mandatory Registration (Pharmacy and Poisons Ordinance, Cap. 138): All pharmaceutical products must meet safety, efficacy, and quality criteria and obtain registration with the Pharmacy and Poisons Board of Hong Kong before sale. Under Board guidance, all injectable substances and advanced therapy products (including gene therapy, somatic cell therapy, and tissue-engineered products) are classified as pharmaceutical products under Cap. 138.
2. Penalties for Illegal Sale or Possession (Cap. 138): Selling (including via the Internet) or possessing unregistered pharmaceutical products or Part 1 poisons constitutes a criminal offence. Conviction carries a maximum penalty of a $100,000 fine and two years' imprisonment.
3. Import and Export Controls (Import and Export Ordinance, Cap. 60): Importing or exporting pharmaceutical products without a proper licence carries a maximum penalty upon conviction of a $500,000 fine and two years' imprisonment.
4. Advertisements Restrictions (Undesirable Medical Advertisements Ordinance, Cap. 231): Cap. 231 restricts or prohibits advertisements likely to lead to the use of medicine or treatment for specified diseases in Schedules 1 and 2 (including benign or malignant tumours) and Schedule 4 orally consumed product claims. First convictions carry up to a $50,000 fine and six months' imprisonment; subsequent convictions carry up to a $100,000 fine and one year's imprisonment. Between January 2023 and August 2026, the DH reviewed over 150,000 advertisements and issued over 1,600 warning letters.
Practical Implications
The enforcement actions highlight several critical considerations for healthcare providers, businesses, and the public in Hong Kong SAR and cross-border context:
- Compliance for Healthcare Providers: Medical practitioners and facilities face both criminal prosecution and disciplinary action from professional regulatory bodies if they administer, stock, or promote unregistered medicines.
- Cross-Border Coordination: The DH actively coordinates with Mainland law enforcement and Hong Kong Customs when illegal advertisements or product distribution involve cross-border elements.
- Consumer Verification Tools: The DH advises the public to check for registration numbers formatted as "HK-XXXXX" on drug packaging, verify facility licensing via the DH "Licence Scanner" mobile app, and check official professional registers.
- Regulatory Development: The Hong Kong SAR Government plans to establish the Hong Kong Centre for Medical Products Regulation within 2026 to further elevate drug and medical device standards.
Frequently Asked Questions
Q1: How does Hong Kong SAR law classify injectable products and advanced therapy products?
A1: Under guidance issued by the Pharmacy and Poisons Board of Hong Kong pursuant to Cap. 138, all products intended for injection into the human body, as well as gene, somatic cell, and tissue-engineered products, are classified as pharmaceutical products requiring registration prior to sale.
Q2: What penalties apply to the illegal sale or possession of unregistered medicines in Hong Kong SAR?
A2: Under Cap. 138, illegally selling or possessing unregistered pharmaceutical products or Part 1 poisons carries a maximum fine of $100,000 and up to two years' imprisonment upon conviction.
Q3: Is the WT1 vaccine registered in Hong Kong SAR or elsewhere?
A3: No. The Department of Health confirmed that WT1 is not registered in Hong Kong SAR, nor does it have any registration record with drug regulatory authorities in Mainland China or any overseas jurisdiction.
Q4: What penalties exist for publishing illegal medical advertisements under Cap. 231?
A4: Upon a first conviction, an offender faces a fine of up to $50,000 and six months' imprisonment. For subsequent convictions, the penalty increases to a fine of up to $100,000 and one year's imprisonment.
Who May Be Affected
Healthcare professionals, private medical facilities, pharmaceutical importers, distributors, advertisers, and the public in Hong Kong SAR.
Cross-Border Context
DH notified Mainland authorities regarding WT1 advertisements on Mainland social media platforms and informed Customs to investigate cross-border importation of unregistered drugs.
What to check next
- Establishment of the Hong Kong Centre for Medical Products Regulation within 2026
- Disciplinary outcomes from the Medical Council and Nursing Council regarding arrested practitioners
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.