Clinical efficacy and safety: rheumatology/musculoskeletal system

The European Medicines Agency's scientific guidelines on clinical evaluation of human medicines used in disorders affecting the joints, bones, muscles and soft tissues help medicine developers prepare marketing authorisation applications.

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

Guidelines

• Reflection paper on regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI)
• Clinical investigation of medicinal products for the treatment of rheumatoid arthritis
• Clinical investigation of medicinal products for the treatment of axial spondyloarthritis
• Clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis
• Clinical investigation of medicinal products for the treatment of psoriatic arthritis
• Clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis
• Clinical investigation of medicinal products used in the treatment of osteoarthritis
• Evaluation of new medicinal products in the treatment of primary osteoporosis
• Medicinal products (non-steroidal anti-inflammatory compounds) for the treatment of chronic disorders
• Clinical investigation of medicinal products for the treatment of gout

Concept papers

• Concept paper on a guideline for allergen products development in moderate to low-sized study populations
• Need for an addendum on the clinical investigation of medicinal products intended for treatment of glucocorticoid-induced osteoporosis