Scientific Guidelines

1. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

   Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

2. Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

   Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

3. Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products

   Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products

4. Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

   Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

5. Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations

   Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations