I am new to RAPS and wanting to network with regulatory professionals with knowledge on the eligibility criteria and regulations surrounding getting a somatic cell therapy through conditional approval in China. Specifically is there a pathway to do a conditional approval after 2 clinical trials instead of 3? Do the eligibility criteria state that the indication for the therapy needs to be life threatening
or a serious illness with unmet medical need?
Be great to connect with ayone in the regen med space.
Thanks
Charlotte
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Charlotte Morgan
Head of R&D
Paddington NSW
Australia
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