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Regulatory Affairs

Clinical trials are strictly regulated activities, whether locally or globally. Full compliance with local regulatory requirements is a must.

HKU-CTC is a holder of a Wholesale Poison Licence and is eligible to apply for Clinical Trial Certificates required for conducting clinical drug trials in Hong Kong and import study drugs into Hong Kong. Its regulatory specialists keep close track of the latest local regulatory requirements and is able to recommend the best regulatory strategies and provide a full range of regulatory affair services including initial and continuing applications, progress and final reporting, and submission of safety reports to the local regulatory authority.

Highlights
Comprehensive regulatory affair services including initial and continuing applications, progress and final reporting, and submission of safety reports
Full understanding of the local regulatory requirements for clinical trials
Holder of Wholesale Poison Licence required for application for Clinical Trial Certificates and import of study drugs