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China’s
attractiveness to foreign drug manufacturers also stems
from the State Drug Administration (SDA) registration
process itself. Unlike clinical trials in the U.S. or
Europe, Chinese clinical trials are closely regulated
by the government, and hence only involve the most elite,
government-endorsed hospitals and physicians, many of
whom chair the national boards and associations for
their respective specialties. Moreover, access to the
country’s best minds, facilities and – subsequently
– publicity, is achieved at a fraction of the
cost of second tier resources in the U.S. and Europe.
In addition, new drugs for important
indications that launch first in China before other
markets worldwide – and involve technology transfers
as a function of moving manufacturing to local plants
– often receive fast-track status from the SDA.
It is as much a matter of medical necessity as it is
of national pride. Serving as the global launch point
for a groundbreaking cancer-killer, for instance, would
enable China to advance its development on technological,
economic, health care, and human rights fronts. New
drugs also receive several years’ patent protection.
(In the old classification system, currently being restructured
subsequent to China’s entry into the World Trade
Organization, new drugs launched first in China received
12 years protection. Drugs new to China, but already
marketed elsewhere, received 8 years protection if manufactured
locally.)
The lower costs of conducting clinical
trials in China combined with an accelerated process
enables a company to potentially spend approximately
US$1 million over a 3-4 year process. Once approved,
costs related to production, marketing and distribution
are also markedly lower in China.
Consequently, the foreign company accelerates
their global time-to-market, improves the visibility
and probability of regulatory approval for their product
in their home country, and experiences a spike in their
portfolio value – while slashing costs throughout.
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