Is Prior Approval from Other Regulatory Agencies Required for Drug Registration in Hong Kong?

When it comes to drug registration process in Hong Kong, one common question that arises is whether prior approval from other regulatory agencies is mandatory. The short answer is no—prior approval from other countries is not a prerequisite for registering pharmaceutical products in Hong Kong.

However, the global registration status of a product plays a significant role in the evaluation process. Here’s what applicants need to know:

1. Global Registration Status Matters  

While prior approvals are not mandatory, applicants are required to submit information about the product’s registration status in other countries. This includes disclosing:

• Whether the drug is registered in any other country
• Any refusals, suspensions, or revocations of the product’s authorization by competent regulatory authorities

This information is critical to comply with DoH guidelines and forms part of the comprehensive documentation required for drug registration process in Hong Kong.

2. Requirements for New Chemical or Biological Entities (NCEs) 

For new chemical entities (NCEs) or biological products, the following documents must be provided:

• Official evidence of product approval (e.g., Free Sale Certificates or Certificates of Pharmaceutical Products)
• These documents must come from two or more of the reference countries (see full list below) * ,as per the Department of Health (DoH) requirements.

3. Exceptions for Innovative or Critical Products 

Applications may still be considered on a case-by-case basis, even if only approved in one reference country or under special designations, provided certain conditions are met. These include:

A. Local Unmet Medical Need in Public Health Emergencies 

If the product addresses a local unmet medical need related to:

• A public health emergency,
• A communicable disease, or
• Other matters of public health importance as defined by international health agencies

Required Document:

• An assessment report on the product's safety and efficacy, prepared by a local expert with:
  
  • Fellowship or equivalent qualification, and
  • At least 5 years of relevant experience

B. Orphan Drug / Breakthrough / Priority Review Designation 

If the product has received designations like:

• Orphan Drug Status
• Breakthrough Therapy
• Priority Review

And is marketed in any one of the reference countries* with clinical data from:

• Local populations or
• Chinese/Asian populations

Required Documents:

1. Expert Assessment Report (including epidemiology, treatment paradigms, and clinical data evaluation)
2. Regulatory Documentation, such as:
   
   1. Post-authorization requirements
   2. Licensing conditions
   3. Periodic safety updates
   4. Post-registration development plans

4. Reference Countries List 

The following countries are recognized as reference markets by the Hong Kong Drug Office:

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Republic of Korea, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK, and USA.

Conclusion

While prior approval from foreign regulatory authorities is not strictly required for drug registration in Hong Kong, it is strongly considered during the evaluation process—especially for new chemical entities and innovative therapies. Depending on the drug’s profile and the presence of local public health needs, DoH guidelines allow for exceptions and special pathways that may expedite approval.

Applicants should prepare comprehensive documentation and consult local regulatory experts to ensure a smooth drug registration process.

With its global regulatory expertise, Freyr supports pharmaceutical companies in navigating Hong Kong’s complex registration landscape.

Consult us today to ensure compliance and accelerate your product’s entry into the market.