Executive summary

Yet the promise of automated end-to-end workflow leading to more efficient and error-free processes, as well as faster time to insight and approval, remains as yet largely unrealized. The advent of electronic standards (eCTD) for filing documents long ago, while proving its worth, has not yet been truly transformational.

Manual and paper-based processes die hard. Friction abounds internally and externally. Internally, pharma companies are still digitizing and harmonizing data. Externally, regulators are only slowly adopting digital and at different rates around the world.

But the lockdown-induced challenges during the pandemic to the way the entire healthcare system operates have changed everyone’s sense of what’s possible and their sense of haste. Digital-first approaches are now widely accepted as the way forward, automation is seen as key and new AI and other software tools to enable the next stages of transformation are almost ready for primetime.

Pharma’s regulatory functions are already streamlining their internal processes to prepare for broader automation, pilots are underway, AI is being tested.

But significant challenges remain. The execution of master data management plans must go right. The talent needed to create, test, validate and deploy the end-to-end document automation processes is going to have to be cultivated. So does a ‘machine-first’ mindset that accepts the primacy of automated over human processes.

The ultimate destination of a dynamic regulatory system in which stakeholders evaluate data in real or near-real time and bring better outcomes to patients and payers faster, is still far from being realized but the path to getting there is at least in place.

Download the full paper.