Best Practices For Conducting Multinational Clinical Trials | Page 9

Table 3.

Approval Timelines by Country

EC, ethics committee; CTA, clinical trial
application; IND, investigational new
drug; SIV, site initiation visit; NDA, new
drug approval; BLA, biologic license
application; NCE, new chemical
entity; CFDA, Chinese Food and Drug
Administration
*Taiwan: Expedited review (2-3 weeks)
can be conducted for protocols already
approved in select countries
**China: CTA approval in China is 9 ± 2
months for NCE (chemical) and 18 ± 2
months for biological IND/MRCT
***Korea: including time to reply
to additional supplements from MFDS,
CTA approval is 30 working days

Standard of care
Despite similarities in the standard of care for a number of larger Asian cities, there is still considerable heterogeneity between countries, healthcare
systems, and research areas. For example, within China, the level of healthcare can vary between urban and rural areas and even between doctors.
Moreover, clinical treatment guidelines may differ between and within countries (e.g., by site), although these differences may be somewhat reduced
with the increased adoption of internationally recognized and accepted treatment guidelines.
Traditional and herbal medicines may be widely prescribed or used clinically in addition to, or in preference to, pharmaceutical options.
Furthermore, a comparator in the US and/or Europe may not be available in some Asian countries and must be replaced with a locally available
drug. Because comparisons cannot be conducted between two investigational drugs or with a non-licensed drug, the intended comparator cannot
be studied at the same time.
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