Spring Intro 2023

16/02/2023

Rationale For Abridged Applications

• The regulatory environment in all industries focusses on providing incentives and fair protection for innovation whilst promoting competition. • It now costs in excess of $2.5 billion and can take 10+ years to develop and register a new drug. • Potential costs are prohibitive for competitors to duplicate preclinical and clinical study package prepared by the innovator. • Abridged applications encourage competition within the pharmaceutical industry by permitting “re-use” of existing preclinical and clinical data after expiry of a pre-determined period of protection. • This in turn reduces developments costs and timelines resulting in the availability of cheaper alternative products on the market place.

The Organisation for Professionals in Regulatory Affairs

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Standalone Applications vs Abridged Applications

Standalone Applications

Abridged Applications

Complete applications that contain all the information necessary to demonstrate the quality, safety and efficacy of the proposed product. Full preclinical and clinical study package – either own studies or literature.

Incomplete applications that don’t include a full preclinical/clinical study package. Cross refer to preclinical and clinical data in the file of an approved “reference product” to fill the gaps.

The Organisation for Professionals in Regulatory Affairs

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