2 min read

Introduction

Hong Kong is a strategic entry point for pharmaceutical companies targeting the Asia-Pacific region. With its transparent regulatory system, international standards, and strong legal framework, Hong Kong offers a stable and efficient pathway for pharmaceutical market access. However, entering this market still requires a well-aligned strategy that accounts for local compliance requirements, distribution networks, and business norms.

Below are the top strategic approaches to successfully enter and grow in Hong Kong’s pharmaceutical sector:

1. Partnering with a Local Hong Kong Company 

Accelerates registration, enhances market credibility, and provides commercial insight.

Collaborating with an experienced local distributor or regulatory consulting firm helps:

  • Navigate Drug Office submission procedures
  • Meet Pharmacy and Poisons Ordinance requirements
  • Tap into existing retail and hospital networks

This approach simplifies logistics and strengthens market positioning through a trusted local presence.

2. Appointing a Local Authorized Representative (LAR) 

Mandatory for foreign pharmaceutical companies to interact with the Drug Office.

The LAR is responsible for:

  • Submitting registration dossiers to the Drug Office
  • Managing official queries and document follow-ups
  • Handling post-marketing surveillance and adverse drug reaction (ADR) reporting

Choosing a qualified and responsive LAR ensures regulatory compliance and operational continuity.

3. Leveraging Reference Country Approvals 

Expedite registration for products already approved in key markets.

Hong Kong recognizes approvals from countries such as the US, UK, Germany, Switzerland, Japan, Canada, and Australia. New Chemical Entity (NCE) approved in at least two reference countries is required for registration in Hong Kong unless the product meets the following requirements (“1+” mechanism scheme):

  1. It is approved with orphan drug designation, breakthrough therapy designation, priority review designation, or equivalent, and marketed in any of the reference countries
  2. Local clinical data (e.g. clinical studies, case reports, case series, real-world data, etc.) related to proposed indication(s) and posology or clinical data generated from Chinese and/or Asian populations related to proposed indication(s) and posology

“1+” mechanism application may qualify for reduced review timelines compared with standard new drug application (NDA).

This reliance model is highly beneficial for companies with globally marketed products.

4. Entering Through Licensing and Distribution Agreements 

Enables quicker access with reduced regulatory risk.

Under this model:

  • The foreign company retains intellectual property rights
  • The local partner registers and distributes the product
  • Sales and marketing efforts are handled locally

It’s a cost-effective option for companies entering with a single or specialized product.

5. Setting Up a Local Office or Subsidiary 

Allows full control of operations and long-term strategy.

Establishing a local branch or subsidiary supports:

  • Direct regulatory engagement
  • In-house sales and promotional teams
  • Faster business expansion and local visibility

Though resource-intensive, this option suits companies planning long-term investment in the region.

Final Thoughts

Hong Kong’s pharmaceutical market is attractive for its regulatory transparency and global alignment. Companies should assess their product type, risk appetite, and market goals before selecting an entry strategy. Whether through partnerships, regulatory representation, or direct investment, local expertise is critical to navigating the pathway efficiently.

Looking to register your product or appoint a trusted representative in Hong Kong? Contact Freyr today.