Hong Kong Pharmaceutical Registration
Your Gateway to China
Regulatory . Certification . Licensing . Assurance
Navigate Hong Kong's sophisticated $2.5 billion pharmaceutical market with expert regulatory guidance. Our Hong Kong-based team provides comprehensive drug registration services to capitalize on this lucrative opportunity with 6.5% projected growth rate, serving as your strategic gateway to the China region.
Why Hong Kong
Lucrative Pharmaceutical Market with Strategic Regional Access
Attractive Market Fundamentals
Hong Kong's pharmaceutical market, valued at $2.5 billion, offers a lucrative opportunity for imported drugs, propelled by:
Market Advantages:
• Sophisticated healthcare system with advanced medical infrastructure
• 7.4 million population with high healthcare spending capacity
• Projected growth rate of 6.5% positioning it attractively for innovative solutions
• Compelling opportunity for pharmaceutical companies looking to expand their global footprint​
Our Hong Kong Services
Exceptional Tax Environment
Hong Kong is renowned for its simple and low tax system offering significant business advantages:
Tax Benefits:
• Only income derived from or generated in Hong Kong is subject to taxation
• No capital gains tax for pharmaceutical investments and transactions
• No value-added tax (VAT) on pharmaceutical products
• No Goods and Services Tax (GST) on pharmaceutical operations
• Simple tax structure reducing administrative burden
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Comprehensive Regulatory Framework
The regulatory framework ensures comprehensive oversight of pharmaceutical products:
Primary Regulatory Ordinances:
• Pharmacy and Poisons Ordinance - Governing Western medicines safety and quality
• Chinese Medicine Ordinance - Regulating traditional Chinese medicines
• Both Western and Chinese medicines are widely used by the Hong Kong population
Additional Regulatory Considerations
However, the regulatory environment presents complexities with multiple ordinances requiring expert navigation:
Complex Regulatory Structure:
• Import and Export Ordinance governing pharmaceutical trade
• Undesirable Medical Advertisements Ordinance regulating promotional activities
• Antibiotics Ordinance controlling antibiotic distribution and use
• Dangerous Drugs Ordinance managing controlled substances​
• Multiple regulatory requirements requiring comprehensive compliance strategies
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Regulatory Standards & Compliance
The regulatory authorities strive to uphold international standards despite these complexities. Successfully navigating these regulatory complexities is crucial for tapping into the potential of Hong Kong's pharmaceutical industry, ensuring accessibility without compromising quality and safety.
Ready to Enter Hong Kong's $2.5 Billion Pharmaceutical Market?
Let's Navigate Your Hong Kong Registration Success
Don't let regulatory complexity delay your Hong Kong market entry. Our Hong Kong-based regulatory experts, with deep knowledge of multiple ordinances and proven track record, are ready to accelerate your pharmaceutical registration in this sophisticated $2.5 billion market with 6.5% growth potential.
Contact us today to discuss how our Hong Kong expertise can unlock opportunities in this strategic gateway to China markets.
Our Experiences
We have successfully secured drug licenses across a wide range of product types, including New Chemical Entities (NCE), generics, biologics/biosimilars, radiopharmaceuticals, drug-medical device combination products, supplements, medical device licenses, and cosmetics licenses. Our extensive experience includes handling diverse product categories such as New Drug Applications (NDA), vaccines, biologics, biosimilars, radiopharmaceuticals, generics, cosmetics, health supplements, and medical devices, ensuring compliance and efficient market entry for all product types.
Marketing Authorization Holder (MAH) Representation as Regulatory and Local Responsible Person in Pharmacovigilance, liaising with the Hong Kong Department of Health (DH), efficiently handling queries and regulatory communications for MAH approval.
Handled Marketing Authorization Transfers, providing regulatory support for inventory transfer and the grace period between Product Owner and Distributor.
Authorization of Importers
Supported tender communications with the Hospital Authority in Hong Kong as the Marketing Authorization Holder.
Provided comprehensive life cycle management services, including variations, pharmacovigilance services such as PSUR submission, ICSR, product defect handling, etc.
Delivered regulatory intelligence reports and dossier gap analysis to facilitate successful market entry.
Handled Product Owner regulatory and Pharmacovigilance Audits.
Our Establishment
To become a Marketing Authorization Holder (MAH) in Hong Kong, an applicant must be a locally incorporated company or legal entity registered with the Hong Kong Companies Registry, with a business scope related to health or pharmaceutical products, and have a permanent address in Hong Kong.
If the applicant is not the product owner, written authorization from the product owner is required to assign the MAH as responsible for the quality, safety, and efficacy of the product.
Responsibilities of the Product Registration Holder (PRH)
1. Ensure that all transactions with the Hong Kong DH are conducted by the appointed person(s).
2. Comply with all legal provisions in Hong Kong and indemnify the government for claims arising from legal breaches.
3. Ensure the accuracy of all submitted quality, safety, and efficacy information, and promptly notify the Authority of any changes.
4. Respond to requests for supplementary data, information, or samples within the specified time frame or request an extension if needed.
5. Applications will be rejected if required documents are not submitted within six (6) months from the first correspondence.
6. Manage all matters related to the quality, safety, and efficacy of registered products, including:
(i) Updates on product quality and compliance with current Good Manufacturing Practice (cGMP).
(ii) Notification of product registration withdrawal with reasons.
7. Provide any documents, items, or information required by the Authority.
8. Obtain prior approval for changes to registered product details such as composition, origin, or labeling.
9. Notify the Authority of changes in correspondence details (e.g., name, address, contact).
10. Inform the Authority immediately if ceasing as the MAH.
11. The Hong Kong DH corresponds only with the existing MAH and does not engage with third parties.
12. Resolve disputes independently, including those involving the product owner or contractual matters, as the Hong Kong DH will not intervene.
Product registration applications in Hong Kong must be submitted via the local online submission platform PRS 2.0 System by the Marketing Authorization Holder (MAH). The MAH must be a locally incorporated company or legal entity registered with the Hong Kong Companies Registry, with a business scope related to health or pharmaceutical products, and have a permanent address.
Compliance with all requirements for system access and usage is mandatory, including the secure handling of authorized tokens used for submissions. The Hong Kong DH reserves the right to approve or reject applications for PRS 2.0 membership.
Overview of Pharmaceutical Product Registration in Hong Kong
The Hong Kong DH, under the Food and Health Bureau (FHB), is the authority responsible for evaluating and approving pharmaceutical products. The process involves multiple steps to ensure that products meet stringent safety, quality, and efficacy standards.
Medicinal Product Classification in Hong Kong
Medicinal products are classified into the following categories:
Biosimilar Products
Pharmaceutical Products / Substances
Medicinal Gas
Pharmaceutical Products Containing a New Chemical or Biological Entity
Advanced therapy product
(Gene therapy, Somatic cell therapy product & Tissue Engineered Product)
Registration Requirements for Pharmaceutical Products in Hong Kong
International
• WHO, ICH, EMA, US-FDA
Local
• Drug registration guidance document
• Hong Kong DH guidelines & Forms
The pharmaceutical product registration process in Hong Kong involves the following key steps:
01
Determine Product Classification
It is essential to properly classify the product, such as distinguishing whether it contains a new chemical or biological entity, is an advanced therapy product, or is a biosimilar.
02
Appoint an Authorized Representative
Foreign manufacturers must appoint a local authorized representative to liaise with Hong Kong DH.
03
Submit Application via Pharmaceuticals Registration System (PRS) 2.0
Applications must be submitted electronically through Hong Kong DH’s online platform, including the complete product dossier.
04
Dossier Submission
The dossier must include comprehensive data on Product information, Manufacturing details, Clinical trial data, stability studies, labeling and packaging materials.
05
Evaluation and Review
Hong Kong DH evaluates the dossier for compliance with safety, quality, and efficacy standards. Additional documents or clarifications may be requested during this phase.
06
Approval and Registration Number Issuance
Upon successful evaluation, the product will be assigned a Hong Kong Product Registration Number (PRN), which authorizes it for sale and marketing in Hong Kong.
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Authority Registration Timeline for Pharmaceutical Products in Hong Kong
Product Category | Timeline for Registration Review | Timeline for License Obtaining |
|---|---|---|
Pharmaceutical Products/Substances | ||
Products with New Chemical/Biological Entity | 5 months | 1 to 2 months |
Biosimilar Products |
*Subject to change, always refer to the official website for the latest information
Authority Registration Fees for Pharmaceutical Products in Hong Kong
Product Category | Application Fees (HKD) | Registration Fees (HKD) | Total Fees (HKD) |
|---|---|---|---|
Pharmaceutical Products / Substances | 1,100 | 1,370 | 2,470 |
Products with New Chemical / Biological Entity | 1,100 | 1,370 | 2,470 |
Biosimilar Products | 1,100 | 1,370 | 2,470 |
*Subject to change, always refer to the official website for the latest information
How can we help?
• Pre-Market Strategic Consulting and Feasibility Assessment
• Regulatory intelligence and market entry strategy
• Product classification and regulatory gap analysis
• GMP compliance auditing and advisory
• Dossier preparation and submission handling
• Local Entity Support
• Life Cycle Management such as post-market surveillance and pharmacovigilance support
• Pre-submission consultation activity with Health Agency
• Import License Application
• Change of Product Registration Holder
• Ad-hoc Regulatory Affairs Consultation
