Best Practices For Conducting Multinational Clinical Trials | Page 6

A Clinical Trial Application (CTA) is submitted for a completely new

China has strict restrictions regarding the transport of human tissue

drug, which allows a full clinical development program (Table 2).8

samples that affects the use of biomarkers. The use of central, local

However, there is no clear, comprehensive guidance for the technical,

laboratory facilities in China may be necessary.

pre-clinical, or clinical requirements at the CTA stage. Technical support
is required to respond to queries and requests for additional data during

In Hong Kong, a Certificate for Clinical Trial/Medicinal Test is required

the CTA review.8 Drugs previously approved in other countries are

to conduct a clinical trial on human beings or a medicinal test on

considered “import drugs”, and the majority will require domestic

animals, including evidence that approval has been received by the

clinical data from China for an Import Drug License (IDA).8 In these

ethics committee of the institution. Payment of the certificate fee and

cases, a CTA could save up to several years’ time in market approval

collection of the certificate should be done in person at the Drug Office

compared to the import drug route.

of the Department of Health.
Table 2.

Regulatory Considerations by Country

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