The Forum for Innovative Regenerative Medicine (FIRM) has published the Practical Guide to the Conditional and Time-Limited Approval Scheme for Regenerative Medical Products in Japan.
This Guide presents FIRM’s perspective on 1) the background to the establishment of the Conditional and Time-Limited Approval Scheme for Regenerative Medical Products (the “Scheme”); 2) relevant notifications and other regulatory documents, including practical regulatory procedures under the Scheme; 3) regulatory reviews of post-marketing approval-condition evaluations and their outcomes; 4) considerations and insights for developing product development strategies; and 5) challenges associated with conducting post-marketing approval-condition evaluations.
Since the introduction of the Scheme in 2014, several regenerative medical products have been launched under the Scheme, while some products have been withdrawn from the market after failing to obtain full approval. Drawing on the development experience of these products and the review processes conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), this Guide has been prepared to promote product development by enabling companies seeking to use the Scheme to understand it correctly and utilize it effectively.
The Guide is intended to support the development of strategies aimed not merely at obtaining approval under the Scheme, but ultimately at obtaining full approval.