Safety and residues: Biological substances other than immunologicals

The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.

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VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines
Real-world evidence

The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.

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HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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