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

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Full ReportPDF(642KB)

By Chapters

Executive SummaryPDF
Chapter 1 IntroductionPDF
Chapter 2 Existing Regulatory RegimePDF
Chapter 3 Control of Drug Manufacturers and Enhancement to the Good Manufacturing Practices SchemePDF
Chapter 4 Pre-market Control of DrugsPDF
Chapter 5 Regulation of Importers/Exporters, Wholesalers and RetailersPDF
Chapter 6 Procurement and Supply of Pharmaceutical Products in the Public and Private Medical SectorsPDF
Chapter 7 Post-market Control of Drugs and PharmacovigilancePDF
Chapter 8 Risk Communication, Education and TrainingPDF
Chapter 9 Penalty ReviewPDF
Chapter 10 Resources Implications and Establishment of a Dedicated Office on DrugsPDF
Chapter 11 Summary of RecommendationsPDF
Annex A Membership and Terms of Reference of the Review CommitteePDF
Annex B Membership of the two SubcommitteesPDF
Annex C Membership and Terms of Reference of the Task Force and Expert GroupPDF
Annex D Implementation PlansPDF
Annex E Recommendations requiring Legislative AmendmentsPDF
Annex F Glossary of TermsPDF
Annex G Chronology of Drug Incidents since March 2009PDF
Annex H Drug Registration CertificatePDF
Annex I Existing Organization of the Pharmaceutical ServicePDF
Annex J Proposed Organization of the Dedicated Office on DrugsPDF
12 Apr 2019