The purpose of the reflection paper considered in the concept paper is to provide recommendations for the planning, collection of data and evaluation of cardiovascular safety of oncology medicinal products taking into account specific issues that apply to the oncology setting with respect to type of medicinal products applied, patients and trials...

The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.