Regulatory expert insight: electronic submission

By Gareth Macdonald and Claire Videau

- Last updated on GMT

Adoption of electronic submission by regulators around the world is good news for drugmakers’ efforts to access emerging markets says industry expert Kate Wilber.

Electronic submission has grown in popularity over the last few years with regulators in countries covered by the International Conference on Harmonisation (ICH) recognising and supporting the approach, particularly for newer biologic drug products.

More recently, however, regulators outside the ICH region have started to look at using some aspects of electronic submission as a way of streamlining the pharmaceutical review process.

This trend, Wilber suggests, is likely to benefit drugmakers who can, potentially depending on how thoroughly electronic submission is adopted, re-file existing dossiers with regulators in such markets with only a minimum of fine tuning.

We also discuss the evolution of the electronic common technical document (eCTD) standard, with a focus on the new regulated product submission (RPS) model which promises to add flexibility to filing for biologics, drugs and medical devices.

Wilber also flags up product information management (PIM) which, in Europe, allows drugmakers to provide prescribing and labelling information in modular way.

A big thanks

in-Pharmatechnologist would like to thank Kate for sharing her insight on the pharmaceutical regulatory space over the last few months.

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