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LIDDS AB: Update on Chinese Conditional Market Approval (CMA) for Liproca Depot UPPSALA, SWEDEN - LIDDS AB (publ) A newly revised guideline from the Chinese National Medical Products Administration (NMPA) has extended the requirements to a full registration dossier for the conditional market approval (CMA). LIDDS licensee Jiangxi Puheng Pharma is therefore aiming to submit the application for CMA for the prostate cancer drug candidate Liproca Depot in China during Q1, 2021. The CMA is a faster regulatory pathway for the approval of a medicine that addresses patients unmet medical needs based on less comprehensive data than is normally required. LIDDS and Jiangxi Puheng Pharma have put intensive joint efforts in compiling the dossier to be able to hand in the application. The recent request of a full registration dossier requires additional documentation that is currently being compiled by LIDDS. Even though this is a shift in the timeline, this ongoing work would otherwise be

Uppsala lanMonica wallterPuheng pharmaJiangxi puheng pharmaChinese national medical products administrationLiproca depotActive surveillanceசெயலில் கண்காணிப்பு