Spring Intro 2023

30/03/2023

How ? Submission Strategy/ Filings

YEAR 1

YEAR 2

YEAR 3

YEAR 4

YEAR 5

YEAR 6

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Phase 2

Phase 3

MAA/NDA

MAA/NDA Post Approval Maintenance

EU/US Submit

CPP Available

JAPAN ?

CH, AU, EU Submit

ROW CMC Development Manufacturing / Supply Chain

ROW MAA non-CPP

ROW MAA CPP dependent

Local Clinical Development

ROW MAA CPP dependent MAA/NDA Post Approval Maintenance

ROW PLANNING

ROW MAA Registrations

ROW Post Approval Maintenance

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Approval under Exceptional Circumstances

• Comprehensive data on the efficacy and safety cannot be obtained even after authorization because • Very rare indications and cannot reasonably be expected to provide comprehensive evidence, or • In the present state of scientific knowledge, comprehensive information cannot be provided, or • it would be contrary to generally accepted principles of medical ethics to collect such information • Application process • Early dialogue – scientific advice/protocol assistance • Submit proposal 6 months in advance of MAA submission • Specific obligations required • program of studies, prescription or administration conditions, product information • Reviewed annually to reassess the risk-benefit balance • Will not normally lead to a full approval

The Organisation for Professionals in Regulatory Affairs

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