scope

In regulatory affairs, some decisions look like a step back but in practice save months and budget. One of them is stopping before submission, not after rejection.

Objective

The manufacturer came to entrypoint following a rejection at the re-registration stage under the national procedure. The rejection closed the pathway to transitioning to the EAEU compliance procedure. The task was to understand the grounds for rejection and identify
a way forward.

Solution

The first step was a full audit of the registration dossier for one product. Not a review of the regulator's deficiencies, but a structural analysis of Module 3 (Quality): cross-referencing data across sections, assessing compliance with EAEU requirements and identifying risks that would have surfaced in any new procedure.

The initial audit took two weeks. Following delivery to the client, a second review was required, taking a further week. The analysis showed the problem was not isolated. Part of the data did not meet EAEU expectations, and certain non-conformities could not be resolved without additional studies or manufacturing changes. The client was unable to address the identified deficiencies.

The decision was not obvious: rather than preparing the dossier for submission, the process was suspended. There was no value in reinforcing a position that was already demonstrably weak.

The project did not proceed to submission, and that was the right outcome. The manufacturer avoided a second rejection, did not lose another year to a procedure with a foreseeable result and incurred no further financial losses.