Best Practices For Conducting Multinational Clinical Trials | Page 4

China remains a key emerging
market for multinational
pharmaceutical companies
and is the world’s 2nd largest
market, with expectations
that it will be first by 2020.

Countries interested in joining the international pharmaceutical market
are employing and enforcing these guidelines, as discussed later.
Furthermore, as drugs become increasingly available, issues related
to comparator drugs may be fewer.
Intellectual property protection
Sponsors have previously expressed concerns about the protection of
intellectual property (IP) in a number of Asian countries. However,
robust IP protection is known to exist in countries such as Singapore,
China, Taiwan, and Korea,5 where specific laws have been developed
and enforced. In China, a revision to the Chinese patent law was enacted

Similar data quality
In our experience, the quality of data in many Asian countries,
particularly those with previous clinical trial experience, is comparable to
that obtained in the US and Europe. Investigators that have been trained
in international pharmaceutical countries help ensure that international
standards are followed. The sponsor or CRO can also enforce adequate

in 2009,6 while Taiwan supports a patent extension for up to 5 years
while a clinical trial is ongoing, and data exclusivity is also available for
up to 5 years.7 In Singapore, IP protection is particularly well enforced,
as is regulatory compliance.5 In other countries, there are continuing
development and improvements in legislation for IP rights.5
Figure 3.

Robust IP Protection

data quality and consistency by employing experienced and reliable
project management teams and monitor ̸