Spotlight on Australia: Life and Health Sciences

When to Engage Regulators for Clinical Trials leading up to submission? For innovative medicines: - FDA - US pre investigational new drug (IND) filing EMA - Europe - pre first patient exposure PMDA - Japan - pre first patient exposure (if Japanese, consider sakigake) TGA Australia - after phase 2 or 3 studies - are positive (NB suggest engaging with the EMA/FDA first) For biosimilars: Before phase 3 studies against originator For non-innovative (generic medicines) Before comparator is finalised for comparative studies (country specific?) MyMedical DEPARTMENT

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