Chapter 20: Cross-border Pharmaceutical Business Models and Practical Product Registration
Hello, entrepreneurs and investors! I am Drew Tang. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. I have witnessed first-hand the vigorous development and profound transformation of Hong Kong's pharmaceutical market. As a "super-connector" linking mainland China with the world, Hong Kong's unique position in the pharmaceutical sector is becoming increasingly prominent. In this chapter, RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. We will provide an in-depth analysis of the cross-border pharmaceutical cooperation models attracting considerable attention, as well as the key points of pharmaceutical product registration in Hong Kong, in the hope of helping you move forward steadily in this market full of opportunities.
Mainland production, Hong Kong private labelling: exploring new models for cross-border pharmaceutical cooperation
In recent years, the “manufactured in Mainland China, Hong Kong-branded” model has become a springboard for many pharmaceutical companies seeking to enter international markets. At its core, this model combines mature, cost-controllable manufacturing capacity in Mainland China with Hong Kong’s strengths as an international financial and trading centre, its brand appeal and its reputation for stringent pharmaceutical regulation, to achieve a “1+1>2” effect. A medicine labelled “supervised in Hong Kong” or “Hong Kong brand” undoubtedly gains an important endorsement of trust when promoted in global markets.
However, this is not a simple “private-label” operation. Under Hong Kong’s Pharmacy and Poisons Ordinance (Cap. 138), all pharmaceutical products sold in Hong Kong must be registered. Even if a medicine is manufactured in Mainland China, its Hong Kong marketing authorisation holder (usually a company holding a Wholesale Dealer Licence) bears full responsibility for its safety, efficacy and quality. This means that the Mainland manufacturer must comply with the manufacturing quality standards recognised by the Hong Kong Department of Health (PIC/S GMP) and undergo the relevant audits. This is a rigorous legal and technical process, not something to be taken lightly.
Advantages of cooperation:Through this cross-border cooperation, companies can not only effectively control production costs but also use Hong Kong as a platform to bring products more conveniently to Southeast Asian and even global markets. For mainland pharmaceutical companies, this is an effective route to internationalising their brands and participating in global competition. I, Drew Tang, understand the key considerations involved. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority. The RGYS team can provide seamless services, assisting you from finding a qualified Hong Kong licensee and assessing mainland production facilities through to completing pharmaceutical product registration.
Hong Kong pharmaceutical product registration (HK-XXXXX) and the new drug approval mechanism
When dealing with medicines, it is important to understand the difference between ‘product registration’ and a ‘licence application’. Simply put, a licence applies to the business entity (the company), while product registration applies to a specific product. Every Western medicine legally sold in Hong Kong must have a unique registration number, usually in the format ‘HK-XXXXX’. This is what is commonly known as a ‘drug registration number’. It indicates that the medicine has been reviewed by the Pharmacy and Poisons Board (PPB) and that its safety, efficacy and quality are controlled.
The medicine registration application process is rigorous and requires submission to the Department of Health of a complete technical dossier covering pharmacology, toxicology, clinical study data, manufacturing processes, quality standards and other matters. The review may take 1–2 years. However, to encourage new medicines to be launched in Hong Kong, the Hong Kong Government introduced the “1+” new drug approval mechanism in 2022. Under this mechanism, a new medicine for a serious or rare disease may be registered in Hong Kong on approval by one, instead of the previous two, designated reference regulatory authorities (such as the National Medical Products Administration (NMPA) or the US FDA), together with local clinical data and endorsement by experts. This significantly shortens the time for new medicines to enter the Hong Kong market.
The significance of the “1+” mechanism: This innovative policy not only enables Hong Kong patients to access new medicines from around the world sooner, but also provides local and overseas pharmaceutical companies with a more efficient registration pathway. I, Drew Tang (Tang Shangyong), consider this an important measure to consolidate Hong Kong's position as an international medical centre. For clients planning to bring new medicines to Hong Kong, Rengangyongsheng (Hong Kong) Limited can assess whether the “1+” mechanism is applicable and assist with preparing and submitting all required application documents.
Regulation of medicine imports and exports, parallel imports and health supplements
In Hong Kong, the import and export of medicines are strictly controlled. Under the Import and Export Ordinance (Cap. 60), an import or export licence issued by the Department of Health is required for the import or export of any pharmaceutical product or medicine. The relevant requirements apply to both commercial consignments and medicines carried by individuals across the border. Medicines containing antibiotics or dangerous drug ingredients are subject to even stricter controls under the Antibiotics Ordinance (Cap. 137) and the Dangerous Drugs Ordinance (Cap. 134), respectively.
Parallel-imported medicines (commonly known as grey-market medicines) are not completely prohibited under Hong Kong law, but they must already be registered in Hong Kong. Selling an unregistered medicine in Hong Kong is illegal even if it is lawful in its country of origin. Parallel importers must also hold the appropriate licence, such as a wholesaler’s licence, and fulfil the notification obligations for importing medicines. I, Drew Tang (Tang Shangyong), must remind everyone that the legal risks of dealing in grey-market medicines are extremely high. Do not take the risk.
Health supplements vs medicines: Many clients ask how to distinguish a health supplement from a medicine. Under the Pharmacy and Poisons Ordinance, if a product contains a controlled western medicine ingredient, or its claimed medicinal properties meet the definition of a “pharmaceutical product”, it will be regulated as a medicine and must be registered. Products sold as “health supplements” or “dietary supplements” in other jurisdictions may be classified as medicines in Hong Kong because of their ingredients or claimed therapeutic effects. A professional review of the ingredients and labelling is essential before a product is introduced.
Rengangyongsheng: Your one-stop compliance partner
From licence applications to product registration, and from cross-border business model design to compliance system development, Hong Kong’s pharmaceutical market offers many opportunities, alongside complex regulatory challenges. Drew Tang and the professional team at Rengangyongsheng (Hong Kong) Limited are committed to providing you with a one-stop solution. We are familiar not only with the legislation, but also with every detail of commercial practice.
| Comparison criteria | Medicine registration (HK-XXXXX) | Medicine business licences (such as a wholesaler licence) |
|---|---|---|
| Regulated parties | Specific pharmaceutical product (Product) | Company entity carrying on pharmaceutical business (Company) |
| Key purpose | Assess the safety, efficacy and quality of medicines | Regulates a company’s qualifications to operate, premises, personnel and management systems |
| Approving authority | Pharmacy and Poisons Board (PPB) | Drug Office, Department of Health (Drug Office) |
| Legal basis | Pharmacy and Poisons Regulations (Cap. 138A) | Pharmacy and Poisons Ordinance (Cap. 138) |
| Necessity | The product’s “identity card” for sale in Hong Kong: registration is required | The company must hold a “business licence” for conducting the relevant business |
| Validity period | Typically 5 years, renewable | Typically 1 year, renewable |
Whether you plan to establish a pharmacy or a pharmaceutical factory in Hong Kong, or want to distribute quality medicines worldwide through Hong Kong, we can tailor the most suitable solution for you and handle the complex paperwork, so you can focus on developing your core business. Choose Rengangyongsheng (Hong Kong) Limited for professionalism, efficiency and peace of mind. Please feel free to contact me to discuss your business plans.