In the last 10 years, more and more clinical trials have come to China because of potential market/easy access
of patient and cost-effectiveness, but if we look back, there had been minimum changes on the regulatory requirements,
and there is a possibility that China government could further strengthen the regulatory requirements for the global
pharma/foreign pharma. In 2013, there was a breaking news that China government would start to investigate the corruption
of GSK. So now, should the global pharma/foreign pharma go to China to conduct clinical trial? If the sponsor wants
to access China market and provide unmet medical needs to China market, there are still many opportunities and there are
ways to get all of these barriers resolved.
Keywords: Clinical trial, regulatory approval, China, patient recruitment, multinational trial, challenge, strategies, market.
Rights & PermissionsPrintExport