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Ready to Enter Hong Kong's $2.5 Billion Pharmaceutical Market?

Our Experiences

Our Establishment

Responsibilities of the Product Registration Holder (PRH)

Overview of Pharmaceutical Product Registration in Hong Kong

Medicinal Product Classification in Hong Kong

Medicinal products are classified into the following categories:

Registration Requirements for Pharmaceutical Products in Hong Kong

International

Local

The pharmaceutical product registration process in Hong Kong involves the following key steps:

01

Determine Product Classification

02

Appoint an Authorized Representative

03

Submit Application via Pharmaceuticals Registration System (PRS) 2.0

04

Dossier Submission

05

Evaluation and Review

06

Approval and Registration Number Issuance

Authority Registration Timeline for Pharmaceutical Products in Hong Kong

Authority Registration Fees for Pharmaceutical Products in Hong Kong

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Commercial Access

License Holding

RLD and Bioequivalence

Regulatory Consultancy

Quality Management

Temperature Validation & Monitoring

Biosimilar Products

Pharmaceutical Products / Substances

Medicinal Gas

Pharmaceutical Products Containing a New Chemical or Biological Entity

Advanced therapy product

Hong Kong Pharmaceutical Registration

Regulatory . Certification . Licensing . Assurance

Lucrative Pharmaceutical Market with Strategic Regional Access

Let's Navigate Your Hong Kong Registration Success

Singapore Malaysia Philippines Vietnam Thailand Hong Kong Taiwan Indonesia Services Commercial Access Regulatory Consultancy License Holding Quality Management System RLD and Bioequivalence Temperature Validation Contact Us Get In Touch 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

License Holding Load More RLD and Bioequivalence Load More Regulatory Consultancy Load More Quality Management Load More Temperature Validation & Monitoring Load More 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

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

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.

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.

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.

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.

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.

(Gene therapy, Somatic cell therapy product & Tissue Engineered Product)

• WHO, ICH, EMA, US-FDA

• Drug registration guidance document

• Hong Kong DH guidelines & Forms

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.

Foreign manufacturers must appoint a local authorized representative to liaise with Hong Kong DH.

Applications must be submitted electronically through Hong Kong DH’s online platform, including the complete product dossier.

The dossier must include comprehensive data on Product information, Manufacturing details, Clinical trial data, stability studies, labeling and packaging materials.

Hong Kong DH evaluates the dossier for compliance with safety, quality, and efficacy standards. Additional documents or clarifications may be requested during this phase.

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.

*Subject to change, always refer to the official website for the latest information

• 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

Our team is dedicated to ensuring your success in one of Southeast Asia’s most dynamic markets. Contact us now for a consultation and let us help you bring your products to market with confidence.

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