Clinical efficacy and safety: anti-infectives for systemic use

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

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

Guidelines

• Evaluation of medicinal products indicated for treatment of bacterial infections
• Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements
• Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to address indication-specific clinical data requirements
• Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis
• Clinical development of medicinal products for treatment of HIV infection
• Clinical evaluation of antifungal agents for the treatment and prophylaxis invasive fungal disease
• Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C
• Clinical evaluation of medicinal products intended for treatment of hepatitis B
• Clinical investigation of medicinal products for the treatment of sepsis
• Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)
• Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
• Treatment and prophylaxis of respiratory syncytial virus (RSV) disease

Concept papers

• Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza
• Non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19