Clinical efficacy and safety guidelines: Alimentary tract and metabolism
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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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