EQUAL CARE® Certification
Medication
Evaluation Criteria
Evaluation Items
Evaluation Description
Methodology
Study Representation
Evaluation Description
Sufficient gender representation in comparison to prevalence in the population present in foundational research.
Methodology
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.
Efficacy / Accuracy
Evaluation Description
Gender-segregated data efficacy.
Methodology
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.
Posology
Evaluation Description
Gender-segregated data for posology.
Methodology
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.
Possible Side Effects
Evaluation Description
Gender-segregated date for possible side effects available.
Methodology
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.
Regulatory Compliance
Evaluation Description
Type of study used for market entry approval.
Methodology
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.
Level of Evidence
Evaluation Description
Level of evidence for market entry
Methodology
Appropriate level evidence to facilitate the market entry and certification process.