Welcome to the Journal of Regulatory Affairs, featuring articles on in vitro diagnostic (IVD) medical devices and the associated workflow between notified bodies and reference laboratories in the EU, the Eurasian Economic Union (EAEU) regulatory pathway, comparability protocols, commercial investigational new drug (IND) applications in the academic setting, and regulatory intelligence on cell and gene therapies.
The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline’s implementation to reduce the need for maintaining dual dossier structures.