Best Practices For Conducting Multinational Clinical Trials | Page 7

In Malaysia, the Clinical Trial Import License (CTIL)/Clinical Trial

South Korea is a preferred location for Phase I studies and has streamlined

Exemption (CTX) must be completed for both new and existing drugs

regulatory processes for Phase II and III studies. The reviews of the ethics

and can be completed by any investigator who is an authorized person

application and Korean Food and Drug application can also occur in

from a locally registered pharmaceutical company/CRO/sponsor with

parallel.4 The majority of the Investigational New Drug (IND) application

a permanent address in Malaysia. However a “License A” holder must

must be in Korean, including the application, protocol, consent form,

submit the CTIL/CTX in the case of a “poison,” which includes a number

non-clinical study report, and clinical study report.

of different drug types. A CTIL/CTX will not be issued prior to ethics
committee approval; however, a simultaneous review by the ethics

In Taiwan, the collection of local clinical data is a key success factor for the

committee and the National Pharmaceutical Control Bureau (BPFK)

mandatory “ethnic sensitivity evaluation” (Bridging Package Evaluation).

is allowed.
Other specific considerations include GMP requirements, which diff