Module 1 2021

25/06/2021

ICH E5: Regulatory Requirements

Complete Clinical Data Package contains: • Adequate characterization of PK, PD, dose-response, efficacy and safety in the foreign population. • Clinical trials establishing dose response, efficacy and safety are: ● in accord with regulatory standards in the new region; ● adequate and well-controlled; ● utilizing appropriate endpoints; and ● using medical and diagnostic definitions acceptable to the new region. • Characterization of PK, PD and dose response in a new region population.

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Impact of Current Requirements

Positive

Challenges

Need to spread/stretch global development across more countries, irrespective of size of organisation – a challenge for the smaller enterprises Differences in regulatory requirements within an evolving picture: how to plan today for tomorrow

Drives early thinking and decisions around clinical development

Increased opportunities for quality pre- consultations and interactions with authorities Authorities recognise differences and are seeking long-term solutions (e.g. Tripartite discussions China, Japan, Korea)

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