Regulation of Advanced Therapy Products

• Pharmacy and Poisons (Amendment) Ordinance 2020
• Commencement Notice
• Slides on Regulatory Update on Advanced Therapy Products in Hong Kong
• Consultation on Regulation of Advanced Therapy Products
  • Consultation Document [2018-04-03]
  • Consultation Report [2018-10-30]
• Promotional Materials
  • Pamphlet (for consumers)
  • Booklet (for healthcare providers)
  • Infographics (Chinese version only)

• Classification of Advanced Therapy Products
  • Guidance on Classification of Advanced Therapy Products With effect from 1 August 2021
• Manufacture
• Drug Registration
  • Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy
    Products With effect from 1 August 2021
• Clinical Trial
  • Guidance on Application of Certificate for Clinical Trial – Advanced Therapy
    Products With effect from 1 August 2021
• Import and Export
  • Guidance on Application of Import and Export Licences – Advanced Therapy
    Products With effect from 1 August 2021
• Labelling of Advanced Therapy Product
  • Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products With effect from 1 August 2021
• Record Keeping
  • Guidance on Record Keeping for Licensed Manufacturers and Licensed Wholesale Dealers – Advanced Therapy Products With effect from 1 August 2021
• Adverse Drug Reaction Reporting
  • Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting
    Requirements With effect from 1 August 2021
• Other Guidance applicable to Pharmaceutical Products

• Classification of Advanced Therapy Products
  • Guidance on Classification of Advanced Therapy Products With effect from 1 August 2021
• Record Keeping
  • Guidance on Record Keeping for Medical Practitioners, Dentists and Institutions Providing Advanced Therapy Product Treatment With effect from 1 August 2021
• Adverse Drug Reaction Reporting
  • Guidance for Healthcare Professionals – Adverse Drug Reaction Reporting With effect from 1 August 2021
• Clinical Trial
  • Guidance on Application of Certificate for Clinical Trial – Advanced Therapy
    Products With effect from 1 August 2021
• Import for the Treatment of a Particular Patient
  • Guidance on Application of Import and Export Licences – Advanced Therapy
    Products With effect from 1 August 2021

• Industry
• Healthcare Professionals
• Consumer

• For Consumer
• For Industry & Researchers