Module 12 2019

Regulatory Authority Activities

JAPAN ➢ Pharmaceuticals and Medical Devices Agency (Japan) will only accept CDISC data from April 2020 US ➢ FDA can (and will) challenge why companies are not able to provide CDISC packages if proposed as legacy. ➢ Legacy filings incur many FDA questions post filing ➢ Real Time Oncology Review cuts down filing timelines to 6 weeks post top line results, this cannot be done without being ready to share eSubmission packages by data base lock • FDA could be rolled out across all filings, not just Oncology if program is successful

The Organisation for Professionals in Regulatory Affairs

2019 Europe Interchange | Amsterdam, Netherlands | 6-10 May 2019

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