China FDA Accreditation

There are 16 China-FDA accredited clinical trial units in The Chinese University of Hong Kong (CUHK)/ Prince of Wales Hospital (PWH)

  • CUHK/ PWH was accredited by China FDA since 2006
  • One of the two accredited hospitals outside Mainland China
  • Study data from 16 research units (13 accredited Specialties) will be recognized by China FDA
  • The only BABE unit accredited by China FDA

China FDA Accredited Research Specialties in CUHK/ PWH

Anaesthesia and Intensive Care Unit
BABE (Bioavailability & Bioequivalence)
Obstetrics and Gynaecology
Otorhinolaryngology, Head and Neck Surgery
Paediatrics (Hematology, Immunology,
Infectious Disease, Respiratory)
Phase 1 Clinical Trial Centre

Audit & Inspection

CRMO Inspection Team:

In order to ensure compliance of our clinical research activities with the protocol, SOPs, ICH-GCP and relevant regulatory requirements, a Clinical Research Inspection Team was established in 2015 to conduct regular, independent and systematic inspection of our Clinical Research Units. The Clinical Research Inspection Team is composed of experienced clinical research colleagues from CRMO, CREC and the current CFDA-accredited units.

Inspections and Audits:

As a part of the quality management system, study sponsors and regulatory authorities will arrange independent audits and inspection for clinical research sites. Our research units underwent numerous audits by international pharmaceutical companies and inspections by regulatory authorities, including US FDA, China FDA and MHLW (Japan). In 2013, PWH Clinical Research has obtained "EA" (Extensive Achievement) in PWH OWS (Organization Wide Survey).