# Open-source dossier-building software for academic sponsors and generic makers

Source: https://onco.cc/ideas/idea-reg-open-source-dossier-tools/  
OnCo record `idea-reg-open-source-dossier-tools` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Preparing a regulatory filing requires expensive specialist software and consultants. Free, open tools would let universities and small generic firms file in more countries.

## Summary

Academic groups that run positive trials of repurposed or de-escalated regimens rarely file for label changes because eCTD authoring, publishing and validation tools are commercial and expensive. The proposal is an open-source toolchain (eCTD v4 authoring, CDISC dataset conversion, validation against regional rules, submission gateway clients) maintained by a foundation, plus templated modules for common academic filings such as new-indication supplements for off-patent drugs.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Within three years of release, at least ten academic or non-profit sponsors file regulatory submissions using the toolchain that they would otherwise not have made, and the cost of a multi-region generic oncology filing falls by half.
- Rationale: Open-source infrastructure has repeatedly lowered barriers where the format is standardised and the buyer base is fragmented (statistics, genomics pipelines). eCTD is a fully specified standard.
- Proposed test: Build the minimum toolchain, use it for two real academic new-indication submissions to FDA and EMA, and publish the time and cost against a consultant-led equivalent.
- Maturity: speculative
- Actor: engineering

## Sources

- Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- bottlenecks: [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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