Module 1 2021

28/06/2021

Provisional Approval for Regenerative medicine products

[Conventional pathway]

Clinical study

Phased CTLs (confirming efficacy and safety)

MA

Marketing

[Additional pathway for RM products]

Follow-up submission within stipulated time period (max. 7yrs)

Marketing (Further data accumulation towards re- submission)

CTLs (confirming safety, likely to predict efficacy )

Conditional term-limited MA

MA

Marketing continues

Clinical study

or Revocation of MA

Distribution to third parties is not allowed

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Early Conditional Approval

Conditions for Eligibility to Early Conditional Approval

1.Serious Disease: life threatening, irreversible disability for daily life…

2. Medical Usefulness: 1- no existing medication, prevention/diagnosis, 2- superior to existing ones from the viewpoint of efficacy, safety, and physical & mental burden of patients

3. I t is assessed that the implementation of confirmatory clinical trial would be difficult or will take considerable amount of time to complete because of the small number of patients etc. , even if it would be feasible

4. it is judged that certain efficacy and safety could be shown with clinical trial data other than confirmatory clinical trials

Distribution to third parties is not allowed

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