Scientific Guidelines

1. Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers

   Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers

2. Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3

   Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3

3. Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

   Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

4. Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application

   Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application