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Preparing a regulatory filing requires expensive specialist software and consultants. Free, open tools would let universities and small generic firms file in more countries.
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.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.