Concept of Draft Guidance on the Need for Contraception Related to Use of Pharmaceuticals (From the Viewpoint of Pharmaceutical Companies)

Abstract

The purpose of “Draft Guidance on the Need for Contraception Related to Use of Pharmaceuticals” is to minimize the potential risk of developmental toxicity and genotoxicity in the offspring of male and female patients treated with pharmaceuticals and to suggest when and for how long contraception should be recommended during and after treatment. This draft guidance may be useful for pharmaceutical companies in determining the necessity for recommending contraception in the labeling of pharmaceuticals. Such recommendations should be based on safety information from nonclinical studies, clinical studies, and post-marketing phase. Together with this information, this guidance will also be useful for physicians treating patients in clinical practice. This report introduces the summary of the draft guidance and provides actions to be taken by pharmaceutical companies according to the draft guidance.