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) infection

Concept papers

Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza

Clinical efficacy and safety: anti-infectives for systemic use

Guidelines

Concept papers

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