Concept paper
The initial stage is the concept paper phase, which is intended to
convey the need for discussing specific issues, innovations or
controversial key-points at any stage of the development of medicinal
products with a view to laying down the foundation for future
guidelines[3]. Comments collected on the concept paper will give
stakeholders to provide directional input on the direction of the future
guideline. Comments provided will be considered in the development of
the future guideline[3].