Blog

A Joint IDMP and Dossier Submission?

When the Identification of Medicinal Products (IDMP) takes effect, the IDMP data package could be submitted as part of the dossier file for health authority validation.

This was one big take away from the recent substance, product, organization, and referential (SPOR) taskforce meeting in March. Not only would this concept of delivering a product data message alongside the dossier be more efficient, it also means that validation and approval from the health authority (NCA) could occur simultaneously for both the IDMP message and dossier.

For this move to be successful, it is arguably even more important for regulatory data to be aligned with IDMP information at submission stage as there won’t be another opportunity to submit IDMP details.

The taskforce is also pursuing the transition of Type 1A variations from document-based to data-only submissions. These ‘do then tell’ filings for administrative tweaks – like a manufacturer’s address change – currently place undue burden on sponsors and health authorities due to their reliance on manual document development and review. This data-centric approach would be much faster and effective.

Against this backdrop, regulatory must move beyond its traditional focus on documents. Managing data is of the utmost importance for tackling IDMP and other regulations, such as the Falsified Medicines Directive and E2B (R3), which also have SPOR requirements.

These proposed changes are helping to blur the line between documents and data. This moves us from a world where everything is managed separately, to the next generation of RIM bringing it all together.

Make it a RIM-win situation for IDMP and other regulations

Implementing a single RIM system that acts as a clearinghouse for all IDMP data, including registration tracking, is the best route for tackling this data-centric shift. It enables you to comply with ever-changing legislation and streamlines operations for more effective working. It’s a fast-track to achieving unified capability, accuracy, and end-to-end delivery across documents and data.

Adding an IDMP-specific tool to tackle the new regulation will introduce challenges. It’s another piece of technology to manage and another link in the data exchange chain, duplicating data and increasing the risk of discrepancies.

Your registration tracking system already holds ~40% of the IDMP data, with the remaining 60% sitting outside of regulatory in various other systems and documents. RIM offers the biggest piece of the puzzle for IDMP and future standards.

Upgrading your registration tracking to incorporate IDMP allows faster, more accurate delivery across all work streams – not just to deal with IDMP, but to equip yourself for the digital age.

Learn how regulatory is becoming increasingly data-centric, watch the webinar.

Veeva Vault RIM is a unified application suite that improves regulatory business operations and compliance by providing a single authoritative source for regulatory content and data.