Conditional Approvals for Early Access to New Medications

Posted 31 May 2017 By Sharry Arora

placeholder+image This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

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Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Japan, FDA, EMA, PMDA, ICH

Tags: Conditional approval, Regenerative medicine

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