A new section on the use of real world evidence (RWE) has been added to the forms for new authorisations of and variations to human and veterinary medicinal products. If an application includes RWE in support of the proof of safety and efficacy, information on the study design and data sources of the RWE must now be included in the forms.
The amended forms are valid as of 1 May 2023. As is customary, the previous versions of the forms can continue to be used for a transitional period of three months.