EQUAL CARE® Certification

Ensure that foundational research includes a gender representation that reflects the prevalence in the population. Companies must provide data demonstrating this balance in their studies, showing that both genders are adequately represented in clinical trials. Deviation up to 25 percentage point will be accepted since exact recruitment can be associated with disproportional efforts in resource and time. In the future we aim to lower this standard.

Provide efficacy/accuracy data segregated by gender. Companies must provide evidence of how the medication/diagnostic/treatment performs separately for men and women. This includes presenting results from clinical trials and other efficacy/accuracy studies.

Provide gender-segregated data for posology (the study of drug dosages). Companies must demonstrate that they have considered gender differences in dosage recommendations and have evidence to support the appropriate dosages for men and women. This includes detailed documentation of clinical trials focusing on dosage variations between genders.

Specify the type of study used for market entry approval. Companies must provide information about the study designs and evidence levels that were used to obtain market approval for their medication. This includes details about clinical trials, observational studies, and any other research methodologies that support the medications safety and efficacy.

Specify the type of study used for market entry approval. Companies must provide information about the study designs and evidence levels that were used to obtain market approval for their medication. This includes details about clinical trials, observational studies, and any other research methodologies that support the medications safety and efficacy.

Appropriate level evidence to facilitate the market entry and certification process.