Bayer is looking for ways to accelerate the regulatory approval process, using digital transformation.
Certain approvals are complex and require large amounts of evidence and specialist analysis. However, some approvals simply require a review of submissions to assess whether changes are within permissible thresholds.
Scope
Prototype focuses on the assessment of equivalence under Regulatory Directive DIR2010-04, Guidelines for Reliance on Proprietary Data Under the Pest Control Products Regulations.
This directive guides people on how to apply for registration of a new source of a registered technical grade active ingredient (TGAI) based on an existing TGAI.
The prototype combines:
Digitisation of the application process
Rules as Code to assess equivalence
Producers can submit their applications online, while also getting results that classify their application as equivalent or needing expert review.
Regulator portal
Regulators can login to the backend of the website/prototype to see submissions sorted into two groups:
Equivalent
Not equivalent (needs expert review)