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
Big data

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...

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HumanVeterinaryCorporateData on medicinesInnovationResearch and development
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
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