Position paper 26 September 2022

Points to consider: The importance of sameness of product in the context of regulatory reliance


IFPMA describes how the R&D-based pharmaceutical industry delivers products with the same quality to all countries around the world, which should facilitate  reliance procedures.

IFPMA notes that mutual trust between all parties is the foundation of reliance, adding that transparency is a key principle for good regulatory practice and fundamental to reliance.

To facilitate reliance activities, IFPMA has developed a template that provides a transparent overview and description of any differences between the documentation submitted for marketing authorization or post-approval changes in the relying and the reference National Regulatory Agency (NRA).




Points to consider pdf | 213KB
Template for description of differences pdf | 116KB