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Drug Development Strategies in China
Pharma and biotech firms who are relative newcomers to the Chinese market aren't aware that the regulatory climate has changed dramatically in recent years. SFDA approval times for Clinical Trials Approvals have dropped to 7-9 months for small molecules. There are also opportunities in China for sponsors that have not yet completed Phase II trials to create a parallel approval strategy. Even without final details (like final dosing) it’s possible to file a CTA for Phase III based on the most current early phase results. This parallel submission strategy can shave several months off the final approval time in China.
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BioClinica
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