Best Practices For Conducting Multinational Clinical Trials | Page 14

An NDA in Taiwan requires a complete data package to ensure safety and

Figure 7.

The Benefits of Working With Local Experts

efficacy. While a rule states that two reference countries must approve
a new drug first, this rule may be waived if a multinational clinical trial,
regional, or local clinical study is conducted in Taiwan. For NCEs that are
available elsewhere, a Bridging Study Evaluation (BSE) can be completed.
The TFDA states the purpose of the BSE “is to provide clinical data, such
as PK/PD, efficacy, safety, dosage, and dose regimen, associated with the
population in Taiwan, so that foreign clinical data can be extrapolated to
the corresponding population of Taiwan, hence minimizing the duplication of clinical trials.” If evaluation of the product has been completed
in a population that reflects Taiwan, even in a foreign country, and the
product is not sensitive to ethnic variations, no further studies may be
required. If sensitivity to ethnicity is detected, then a bridging study is
required. However, local experience suggests that local clinical data is
a key success factor for this application, and the protocol may need to
include plans for locally collected data.
In Vietnam, a domestic drug manufacturer must meet the GMP standards
of the Health Ministry while foreign drug manufacturers must satisfy
GMP standards that are at least equivalent to the WHO-GMP.20

How can Clinipace Worldwide help with
entry to Asia? »
Clinipace Worldwide, as a global CRO, has recognized abilities in clinical trial design and experience with over 1,800 global clinical research
studies, strategic product development projects, and regulatory engagements. With the recent acquisition of Choice Pharma, a Pan-Asian CRO,
Clinipace acquired offices and local knowledge in Taiwan, China, Hong
Kong, South Korea, Vietnam, Singapore, and Malaysia that are available
to assist companies new to Asia gain entry to those countries.

These local experts are positioned and available to assist with regulatory
requirements, local legal representation for contracts and payment
processes, comparator availability, local clinical/treatment guidelines,
and availability and suitability of both PIs and sites. Proactive risk
mitigation during protocol development saves time and headaches later,
while experience with “rescue” trials can help sponsors save a trial that
is not progressing due to unforeseen challenges with local regulatory
requirements or recruitment.
Trust-based relationships with investigators and sites that have been
developed over time by local CROs are of great significance. In some
Asian countries, the existence of these relationships prior to protocol
development, when investigators and sites are being chosen, can
deter-mine the success of the trial. Local CROs can help select a site
and PI that will accommodate even a difficult study and will even
provide advice for successful study completion.
clinipace.com

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