Hong Kong Drug Office Publishes Frequently Asked Questions for Clinical Trial Certificates

Hong Kong Drug Office has published a set of frequently asked questions on the application for clinical trial certificate (CTC) in June 2022. 

The document covers some pertinent topics, including the general principles, application procedure, and definition or glossary of key words in relation to clinical trial certificates. 

Some of the questions relate to the application of a CTC and whether or not it is required before clinical trials are conducted on humans, observational studies, and off-label use. 

There is also some information on how to proceed for application, the fees, and the appeal process if an applicant does not agree with the final decision. 

More details can be found in “Frequently Asked Questions on Application for Clinical Trial Certificate, June 2022”: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/FAQ_modified_en.pdf?v=asllmlhaor  


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