Clinical efficacy and safety guidelines: nervous system

The European Medicines Agency's scientific guidelines on the clinical evaluation of medicines used in nervous-system disorders help medicine developers prepare marketing authorisation applications for human medicines.

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

Guidelines

• Clinical development of medicinal products for the treatment of autism spectrum disorder (ASD)
• Clinical development of medicinal products intended for the treatment of pain
• Clinical investigation of medicinal products for the treatment and prevention of bipolar disorder
• Clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
• Clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)
• Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy
• Clinical investigation of medicinal products for the treatment of multiple sclerosis
• Clinical investigation of medicinal products in the treatment of Myasthenia Gravis
• Clinical investigation of medicinal products for the treatment of obsessive compulsive disorder
• Clinical investigation of medicinal products for treatment of migraine
• Clinical investigation of medicinal products in the treatment of depression
• Clinical investigation of medicinal products in the treatment of epileptic disorders
• Clinical investigation of medicinal products in the treatment of Parkinson's disease
• Clinical investigation of medicinal products indicated for generalised anxiety disorder
• Clinical investigation of medicinal products indicated for panic disorder
• Clinical investigation of medicinal products indicated for the treatment of social anxiety
• Clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia
• Concept paper on the need for the guideline on the clinical investigation of medicinal products for the treatment of inherited retinal dystrophies - Scientific guideline
• Development of medicinal products for the treatment of alcohol dependence
• Development of medicinal products for the treatment of post-traumatic stress disorder
• Development of new medicinal products for the treatment of smoking
• Clinical investigation of medicines for the treatment of Alzheimer's disease
• Medicinal products for the treatment of insomnia
• Treatment of premenstrual dysphoric disorder

Points to consider

• Clinical investigation of medicinal products for the treatment of acute stroke