Global Regulatory Update

CELL AND GENE THERAPY INSIGHTS

June 2019

Global Regulatory Update

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Editorial

European developments in ATMP Regulation

European developments in ATMP Regulation

Christiane Niederlaender

Perspective

Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Neil WA McGowan, John DM Campbell

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

Oliver Ball, Sarah Robinson, Christopher Bravery

Gene therapy success: how to keep its promises and improve – a regulatory perspective

Gene therapy success: how to keep its promises and improve – a regulatory perspective

Filomena Nappi, Francesca Capone, Maria Cristina Galli

The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

A Kuta, E Sawyer, M Cantor et al.

Interview

Korea’s evolving regulatory landscape for cell & gene therapies

Korea’s evolving regulatory landscape for cell & gene therapies

US FDA goals and priorities for cell & gene therapy regulation

US FDA goals and priorities for cell & gene therapy regulation

Update on the regulatory environment for ATMPs in Israel

Update on the regulatory environment for ATMPs in Israel

Regulatory Insight

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Y Maruyama, M Kasai, Y Fujiwara et al.