ICH Topic E1 – Population exposure: the extent of population exposure to assess clinical safety

 About this guideline

Overseas effective date:  June 1995

Categories: ICH | Efficacy

Clinical efficacy and safety | General

TGA annotations:

Attention is drawn to:

• Applicability, Section 7, which states that circumstances exist in which the Guidelines may not be applicable. It should be noted that the listing of exceptional circumstances is not exhaustive. Sponsors should give careful attention to whether, in any particular instance, the clinical safety of the product would be adequately supported by the numbers of subjects proposed, and;
• Supplementary data, Section 8 is NOT ADOPTED. To permit decisions within legislated timeframes, the sponsor should include in the initial submission all clinical safety data necessary to support registration.

For more information see International scientific guidelines adopted in Australia.