Conditional Marketing Authorisation | PharmaBharat Tools

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Conditional Marketing Authorisation | PharmaBharat Tools

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Accelerated Approval Breakthrough Therapy Designation(BTD)Conditional Marketing Authorisation Fast Track Designation Orphan Drug Designation PRIME Priority Review Priority Review Voucher(PRV)Regenerative Medicine Advanced Therapy(RMAT)Rolling Review Rolling Submission

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RA Expedited & Special ProgramsConditional Marketing Authorisation

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Breakthrough Therapy Designation (BTD)Fast Track Designation

Conditional Marketing Authorisation

Expedited & Special Programs

Definition

An EU mechanism allowing early approval on less comprehensive data than normally required when the benefit of immediate availability outweighs the risk, with specific obligations to provide comprehensive data post-authorisation.

Regulatory source

EU Regulation (EC) 507/2006