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.

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HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
Biostatistics

The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.

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HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
Biologicals: finished product

The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
Quality: specific types of products

The European Medicines Agency's scientific guidelines on specific types of products help medicine developers prepare marketing authorisation applications for human medicines.

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HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
Quality: non-immunologicals
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VeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
Novel therapies
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VeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific guidelines