Survey on Administrative Procedures and Terminologies for Quality Variations/Post-Approval Changes:
This article prepared by the IPRP Quality Working Group (QWG) describes the results of a survey of members and observers of QWG on their terminologies and procedural aspects for Quality variations/post-approval changes. With input from 16 regulatory authorities and organisations, the paper is intended to assist both regulators and the pharmaceutical industry in clarifying differences and aims to increase an understanding of the procedures used for changes to Active Pharmaceutical Ingredients (APIs) and drug products (e.g., reporting levels, categories of changes for prior-authorisation or notification). In addition, this work could potentially support international collaborative efforts on information sharing and regulatory convergence. Having received input from many regulatory authorities and organisations, the information compiled in this paper creates a unique opportunity to increase the knowledge and comprehension to navigate some of the complexities in regulating pharmaceuticals globally.
It should be noted that this article reflects information that was current at the time of its publication on the IPRP website. It may be updated periodically to reflect further developments or to include information for new regulatory authorities and organisations that have joined IPRP since its original development and publication.