Hong Kong has recently revised the process for clinical trials. Thanks to new legislation just passed in February 2015, the process for clinical trials has been simplified. The new legislation took effect on 6 February 2015 and has 2 major implications. First, investigational product samples are no longer required for the application. The second change is that the validity of regulatory approval once granted has been extended to 5 years from the previous 2 year time frame.
1. Investigational product samples are no longer required for the application
Before February’s new legislation took effect, product samples were part of the clinical trial application in Hong Kong. Now that this step is no longer required, the time that it takes to submit a regulatory application is greatly reduced and the application process is simplified significantly.
2. The validity of regulatory approval has been extended from 2 years to 5 years
Once a company has received approval, it is valid for 5 years instead of only 2 years. This eliminates the time consuming task of having to re-submit documents after only 2 years. The new 5 year rule applies to new applications and renewals moving forward. Therefore, companies now only have to repeat the re-submission process every 5 years. If the study being conducted is less than 5 years, those trials will not need a re-submission.
This new ruling makes clinical trials in Hong Kong much easier to work with compared to other countries. For example, Malaysia’s regulatory approval process is valid for 3 years. In Taiwan, the regulatory approval does not expire; but the import license is only valid for 3 years.
For George Clinical, our East Asia operations are headquartered in Hong Kong. From there, we oversee the ground operations in Hong Kong, Taiwan, and Malaysia. This base also enables coverage of other South East Asian countries like Singapore and Philippines.
CRO services in Hong Kong and East Asia
|In country services||Centrally supported services|
|Site Management & Monitoring|
Read more about services provided from our Hong Kong office.