By Elke Debie
Published in: Sci of Stability Conference
Published on: October 14, 2019
Summary Statement: • Some early adopters have been filing RBPS data for over a decade, and the regulatory acceptance has been high • More companies started to use RBPS and to file the data in submissions • Support pharmaceutical development (P.2) (Formulation, packaging, comparability after changes) : usually no queries • Support initial retest period/shelf life with RBPS only and a commitment for long term and accelerated stability • Acceptable by FDA and several other authorities • Often challenged by some countries, e.g., Germany and UK, but acceptable if standard stability data is provided during the review cycle • There has been a noticeable drop off in direct acceptance since 2017 in some EU countries, which seems align with the 2017 EMA “Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials” (EMA/CHMP/QWP/545525/2017) Key Words: Pharmsci, course, regulatory
