Comparative analysis of the information reported on labels of medicinal products containing new active substances between Europe and the USA.

INTRODUCTION: Although notable efforts have been made to harmonise regulatory processes for the approval of new therapeutic drugs by the competent authorities, some discrepancies concerning risk-benefit assessments and regulatory actions remain. METHODS: This analysis compared the approaches of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the approval of new active substances and identified potential clinical implications associated with these differences in "Indication", "Contraindications" and "Posology and administration of drugs" sections of drug summary of products characteristics (SmPC). RESULTS: The overall analysis showed major differences in 63.9% for the indications, in 75% for contraindications and in 13.9% for posology. Considering the more represented therapeutic areas (cancer and haematology/haemostaseology drugs), the percentage of major differences for the indications was 70% in cancer area and 50% in haematology/haemostaseology area. For contraindications major differences were observed in 90% of cancer drugs, and 60% in haematology/haemostaseology drugs. DISCUSSION: Our findings highlight the need of further efforts on harmonizing decision making driven by scientific data between regulatory authorities in the interest of patients in a public health perspective.