Registration of Advanced Therapy Products in Hong Kong: A Comprehensive Guide

Advanced Therapy Products (ATPs) represent the cutting edge of medical innovation, offering new treatment possibilities for various conditions. This guide provides comprehensive information about the registration process for ATPs in Hong Kong.

What are Advanced Therapy Products?

ATPs are pharmaceutical products for human use that include:

1. Gene Therapy Products

   • Products containing recombinant nucleic acid sequences
   • Used to regulate, repair, replace, add, or delete genetic sequences
   • Administered to humans for therapeutic purposes

2. Somatic Cell Therapy Products

   • Products containing cells or tissues
   • Manipulated to change their biological characteristics
   • Used for therapeutic purposes

3. Tissue Engineered Products

   • Products containing cells or tissues
   • Modified to repair, regenerate, or replace human tissue
   • May contain viable or non-viable cells

Registration Requirements

Basic Requirements

1. Legal Framework

   • Regulated under Pharmacy and Poisons Ordinance (Cap. 138)
   • Must meet safety, efficacy, and quality criteria
   • Requires Certificate of Drug/Product Registration

2. Applicant Eligibility

   • For Hong Kong manufactured products:
     • Licensed manufacturer, or
     • Licensed wholesale dealer contracting with the manufacturer
   • For imported products:
     • Licensed wholesale dealer, or
     • Hong Kong branch/representative of overseas manufacturer

Documentation Requirements

1. Essential Documents

   • Authorization letter from overseas manufacturer (if applicable)
   • Business registration certificate
   • Manufacturer's license
   • GMP certificate
   • Free sale certificate
   • Registration approvals from reference countries

2. Product Information

   • Prototype sales pack
   • Package insert
   • Labeling information
   • Product specifications
   • Manufacturing details

Technical Requirements

Quality Requirements (Module 3)

1. Manufacturing Process

   • Detailed process description
   • Quality control procedures
   • Validation protocols
   • Stability data

2. Product Characterization

   • Physical and chemical properties
   • Biological activity
   • Purity and impurities
   • Specifications

Non-Clinical Requirements (Module 4)

1. Pharmacology Studies

   • Primary pharmacodynamics
   • Secondary pharmacodynamics
   • Safety pharmacology

2. Toxicology Studies

   • Single and repeated dose toxicity
   • Genotoxicity
   • Carcinogenicity
   • Reproductive toxicity
   • Immunotoxicity

Clinical Requirements (Module 5)

1. Clinical Development

   • Phase I-III clinical trials
   • Safety and efficacy data
   • Long-term follow-up
   • Risk management plan

2. Special Considerations

   • Surgical procedures
   • Device compatibility
   • Healthcare professional training
   • Manufacturing process changes

Special Requirements by Product Type

Gene Therapy Products

1. Pharmacokinetics

   • Shedding studies
   • Biodistribution studies
   • Gene expression studies

2. Safety Studies

   • Replication competent vector
   • New strain emergence
   • Insertional mutagenicity

Somatic Cell Therapy Products

1. Biodistribution

   • Cell persistence
   • Engraftment studies
   • Long-term effects

2. Safety Assessment

   • Distribution patterns
   • Ectopic engraftment
   • Oncogenic transformation

Tissue Engineered Products

1. Product Characterization

   • Component persistence
   • Degradation studies
   • Regeneration evidence

2. Safety Evaluation

   • Distribution patterns
   • Engraftment studies
   • Tissue lineage fidelity

Application Process

1. Submission

   • Use Pharmaceutical Registration System 2.0 (PRS2.0)
   • Pay application fee (HK$1,100)
   • Submit all required documents

2. Review Process

   • Initial screening
   • Technical evaluation
   • Committee review
   • Decision making

Post-Approval Requirements

1. Monitoring

   • Adverse event reporting
   • Periodic safety updates
   • Long-term follow-up

2. Compliance

   • GMP maintenance
   • Quality control
   • Documentation updates

Contact Information

For further information or assistance:

• Pharmacy and Poisons Board

  • Website: www.ppbhk.org.hk

• Drug Office, Department of Health

  • Website: www.drugoffice.gov.hk