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 reiview of submissions to assess whether changes are within permissible thresholds.
This prototype focuses on the assessment of Tier 1 equivalence, as per the Guidance Document on the Assessment of the Equivalence of Technical Materials of Substances Regulated Under Regulation (EC) No 1107/2009, and the relevant legislation found in Annex IIA of the Directive 91/414/EEC.
The prototype combines digitisation of the application process with Rules as Code to assess equivalence. Producers can submit their applications online, while also getting results that classify their application as tier 1 or tier 2.
Regulators can login to the backend of the website/prototype to see submissions sorted into tier 1 equivalent or tier 2 review required. The aim is the speed up the process for regulators and producers, alike.