Regulatory benchmarking

#1 priority

Centralizing regulatory over the next 24 months

Initiatives in place to harmonize function across divisions, geographies

• 54% Identified areas where digital technology adds value54% Harmonized global processes across regulatory operations
• 40% Selected digital technology
• 13% Implemented a digit global regulatory information management (RIM) system for end-to-end regulatory management
• 11% have a global RIM system

Few areas with positive shifts from 2021 to 2022

Collect global registration data in a single system, with all data collected once & available real-time

2021 – 8%

2022 – 14%

Global content reuse across submissions, regions, business units is an area of industry modernizing in the next two years

2021 – 54%

2022 – 57%

Have an integrated file share across regions to archive, view published submission output

2021 – 23%

2022 – 31%

Have a standard global process for archiving with automated compilation

2021 – 13%

2022 – 15%

Have a unified system for forecasting, planning, and tracking submissions

2021 – 13%

2022 – 16%

Key areas for improvement:

83% capture post-market changes for products using partial integrations, siloed solutions, manual processes – increasing the risk of missing key product updates

70% manage regulatory content on local laptops, file shares, regional document management systems

51% collect Unique Device Identification (UDI) data from multiple sources

41% review, approve, publish regulatory submissions individually, via email

21% don’t have a governance structure in place, slowing the ability to register UDI data, assess the impact on UDI attributes

1% have a unified RIM system that provides automated analytics; most rely on manual processes to generate regulatory reports, track performance

Download the report: https://go.veeva.com/regulatory-benchmark-fdanews