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Other IRB & Research Organization
HKU Clinical Trials Centre (HKU-CTC)
HKU Clinical Trials Registry (HKUCTR)
HKU/HA HKW Institutional Review Board (HKU/HA HKW IRB)
Useful Links
Hospital Authority (HA) Guide On Research Ethics
Clinical Research: Management and Compliance at Study Sites
ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Regulations
Guidance on Application of Certification for Clinical Trial – Advanced Therapy Products (ATPs). Version 1.0
Guidance Notes on the Application for Certificate for Clinical Trial/Medicinal Test. Version Jun 2022
Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirement. Version 1.0
Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. Version 5. 10/02/2022
Regulatory & Governmental Bodies
Department of Health (DOH), Hong Kong
Department of Health and Human Services (DHHS), US
Food and Drug Administration (FDA), US
Hospital Authority (HA), Hong Kong
Office for Human Research Protections (OHRP), US
National Medical Products Administration (NMPA), China
International Organizations
College of American Pathologists (CAP)
International Conference on Harmonisation (ICH)
World Health Organization (WHO)
World Medical Association (WMA)
Pharmaceutical or Clinical Research Organizations
The Hong Kong Association of the Pharmaceutical Industry
The Pharmaceutical Society of Hong Kong
The Association of the British Pharmaceutical Industry (ABPI)
The Pharmaceutical Research and Manufacturers of America (PhRMA)