National Medical Products Administration (NMPA) Accreditation
16 NMPA accredited clinical trial units at The Chinese University of Hong Kong (CUHK)/ Prince of Wales Hospital (PWH)
- CUHK/ PWH was accredited by NMPA since 2006
- One of the four accredited hospitals outside Mainland China
- Study data from 16 research units (13 accredited Specialties) will be recognized by NMPA
- The only BABE unit accredited by NMPA
AC Diagnostics and ISO15189 Plus
Our AC Diagnostics and ISO15189 Plus accredited laboratories in Prince of Wales Hospital (PWH) can provide on-site diagnostic testing if needed.
Inspection & Audits
CRMO Inspection Team
To ensure that our clinical research activities are complying with the protocol, SOPs, ICH-GCP, and relevant regulatory requirements, our CRMO Inspection Team conducts regular, independent and systematic inspections of our clinical research units.
Inspections and Audits
Our research units underwent numerous audits by international pharmaceutical companies and inspections by regulatory authorities, including US FDA, Japan PMDA and NMPA.
| Years | US FDA | Japan PMDA | NMPA |
|---|---|---|---|
| 2002 |  |
-- | -- |
| 2003 | -- | |
-- |
| 2006 | -- | -- | |
| 2009 | -- | -- | |
| 2011 | |
-- | -- |
| 2012 | -- | -- | |
| 2016 | |
-- | |
| 2019 | -- | -- | |
Experienced Research Personnel
83%
Investigator with ≥5 years clinical research experience
100%
Research Personnel are ICH-GCP trained
Harmonized SOP
We have developed a harmonized set of Standard Operating Procedures (SOPs) applicable to all clinical departments in our hospitals