RPS Table of Contents Pilot

The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The Table of Contents (ToC) Working Group has previously conducted pilots for both Non-IVD and IVD ToC structures, using historical submissions. This pilot is being conducted with the following general objectives:

• To evaluate the adaptability of the ToC structure from an industry perspective when applying to more than one jurisdiction (simultaneously or sequentially) using real regulatory submissions.

The pilot was initiated on 1 October 2015, and is projected to run for a minimum of twelve (12) months or until all objectives are met. Upon conclusion, all findings will be posted on the IMDRF website.

Further information about this pilot is available here.