Jun. 22, 2017
In order to ensure the quality of clinical trials conducted in Hong Kong, a certificate of permission must be received before conducting any clinical trials there.
All clinical trials conducted in Hong Kong must :
Recognizing that procedures may be overly stringent, the Hong Kong government implemented two new pieces of legislation on the February 6, 2015.
The purpose was to make its regulatory process for clinical trials as efficient as possible while maintaining the highest safety standards.
Before this piece of legislation was implemented, those who wished to conduct clinical trials had to submit investigational drug samples as part of the clinical trial application to acquire an import license. Eliminating this step significantly reduced the time required to complete the application process.
In the past, two years was the maximum length of official approval a company received to conduct clinical trials. This period has now been extended to five years, so that companies no longer have to resubmit applications in order to complete clinical trials, which usually take between two and five years.
Extending the period of validity has also given Hong Kong an international competitive edge in the field of clinical trials: Malaysia offers a validity period of only three years, and in Taiwan import licenses are valid for three years.