Clinical efficacy and safety: alimentary tract and metabolism

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the gut and metabolism help medicine developers prepare marketing authorisation applications

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Clinical investigation of medicinal products for the management of Crohn's disease
• Clinical investigation of medicinal products for the treatment of chronic constipation
• Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus
• Clinical evaluation of medicinal products used in weight control
• Clinical evaluation of medicinal products used in weight control - addendum on weight control in children
• Development of new medicinal products for the treatment of ulcerative colitis
• Evaluation of drugs for the treatment of gastroesophageal reflux disease (GORD)
• Evaluation of medicinal products for the treatment of irritable bowel syndrome
• Non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy

Reflection paper

• Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

Points to consider

• Wording of Helicobacter pylori eradication therapy in selected summary-of-product-characteristics sections