Asia

Australia

 Agency web site (TGA)


COR-A FRP Detail Summary

COR-B FRP Detail Summary


FRP Flow Chart

Indonesia

 Agency web site (NADFC)


Path I (serious life-threatening)

Path II (prior approved by reference)

Path IV (new life saving drugs) FRP Detail Summary

Path V (prior approved drugs) FRP Detail Summary

FRP Flow Chart

Malaysia

Philippines

 Agency web site  (PDEA)

Facilitated registration FRP Detail Summary

FRP Flow Chart

SIAHR ASEAN RRI

 Agency web site (ASEAN)

Joint Assessment FRP Detail Summary

FRP Flow Chart

South Korea

 Agency web site  (MFDS)

 Prior review FRP Detail Summary

FRP Flow Chart

Taiwan (Chinese Taipei)

Thailand

 Agency web site  (Thai FDA)

 FRP Detail Summary

FRP Flow Chart

Vietnam

 Agency web site  (DAV)

 FRP Detail Summary

FRP Flow Chart

Download Asian FRP Details (A-L)

INDONESIA Path I - FRP detail6feb2020 (pdf)

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INDONESIA Path II - FRP detail 6feb2020 (pdf)

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Download Asian FRP Details (M-S)

Malaysia - ABRIDGED FRP detail 15jan20 (pdf)

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Malaysia - VERIFICATION FRP detail 15jan2020 (pdf)

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Pakistan - Conditional MA FRP detail template v18dec19 (pdf)

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Pakistan - Priority Review FRP detail v18dec19 (pdf)

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Philippines fac registration - FRP detail 5feb2020 (pdf)

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SIAHR- ASEAN FRP detail 12Jan2020 (pdf)

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Singapore CECA Scheme Verification FRP detail v18dec19 (pdf)

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Singapore GDA Abridged Route FRP detail v18dec19 (pdf)

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Singapore GDA Verification FRP detail v18dec19 (pdf)

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Singapore NDA Abridged Route FRP detail v18dec19 (pdf)

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Singapore NDA Verification FRP detail v18dec19 (pdf)

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South Korea Prior review detail 15jan2020 (pdf)

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Download Asian FRP Details (T-Z)

Taiwan Abbreviated Review FRP detail14jan20 (pdf)

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Taiwan Accelerated Approval FRP detail 14jan20 (pdf)

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Taiwan Priority Review FRP detail 14jan20 (pdf)

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Thailand - abridged FRP detail 6feb2020 (pdf)

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Vietnam - abridged proc FRP detail 5feb2020 (pdf)

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