Conditional and Time-limited Authorization of Regenerative Medical Products

Published by IRDiRC

Regulatory AffairsMarketing AuthorisationAdvanced Therapy ProcedureMHLW or PMDA Regenerative Medical ProductsPMD ActCTARP

A regulatory framework for the approval of regenerative medical products to benefit the patients with unmet medical needs under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)

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REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

Published by EC

Advanced TherapyMarketing Authorisation

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

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