New legislation has taken into effect which simplifies the Hong Kong regulatory process for clinical trial application in that country. The amendments, which took effect on 6 February 2015, has 2 major implications:
1) Investigational product samples are no longer required for the application
Previously, product samples were part of the clinical trial application. The removal of this step reduces the time required to submit a regulatory application and simplifies the requirements.
2) The validity of regulatory approval, once granted, has been extended from 2 to 5 years
As the requirements for a renewal is the same as a new application, the re-submission of documents is a time consuming task. With the extension of the validity, this task is now repeated every 5 years instead of 2. For studies shorter than 5 years, no re-submission will be required.
Compared to other countries in the region, the regulatory approval for Malaysia is valid for 3 years. In Taiwan, the regulatory approval does not expire, however, import licenses are only valid for 3 years.
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