Report of the Review Committee on
Regulation of Pharmaceutical Products in Hong Kong

Full Report (PDF file, 642KB)

By Chapters

• Executive Summary (PDF file)
  
  
• Chapter 1 Introduction (PDF file)
  
  
• Chapter 2 Existing Regulatory Regime (PDF file)
  
  
• Chapter 3 Control of Drug Manufacturers and Enhancement to the Good Manufacturing Practices Scheme (PDF file)
  
  
• Chapter 4 Pre-market Control of Drugs (PDF file)
  
  
• Chapter 5 Regulation of Importers/Exporters, Wholesalers and Retailers (PDF file)
  
  
• Chapter 6 Procurement and Supply of Pharmaceutical Products in the Public and Private Medical Sectors (PDF file)
  
  
• Chapter 7 Post-market Control of Drugs and Pharmacovigilance (PDF file)
  
  
• Chapter 8 Risk Communication, Education and Training (PDF file)
  
  
• Chapter 9 Penalty Review (PDF file)
  
  
• Chapter 10 Resources Implications and Establishment of a Dedicated Office on Drugs (PDF file)
  
  
• Chapter 11 Summary of Recommendations (PDF file)
  
  
• Annex A Membership and Terms of Reference of the Review Committee (PDF file)
  
  
• Annex B Membership of the two Subcommittees (PDF file)
  
  
• Annex C Membership and Terms of Reference of the Task Force and Expert Group (PDF file)
  
  
• Annex D Implementation Plans (PDF file)
  
  
• Annex E Recommendations requiring Legislative Amendments (PDF file)
  
  
• Annex F Glossary of Terms (PDF file)
  
  
• Annex G Chronology of Drug Incidents since March 2009 (PDF file)
  
  
• Annex H Drug Registration Certificate (PDF file)
  
  
• Annex I Existing Organization of the Pharmaceutical Service (PDF file)
  
  
• Annex J Proposed Organization of the Dedicated Office on Drugs (PDF file)