ideasIdea
One structured global dossier: submit the cancer drug file once, to a shared cloud
Companies currently reformat the same evidence for every country; a single machine-readable dossier that every regulator reads from would save years of work.
ICH M4 (the Common Technical Document) harmonised the outline but not the practice: sponsors still produce dozens of regional variants and submit through separate gateways. The proposal is a shared, permissioned cloud repository holding a single eCTD v4 dossier with structured CDISC clinical data, to which any participating regulator is granted read access on the sponsor's instruction, with region-specific content limited to an annex. Regulators would query the same data and share questions.
Hypothesis
A single-dossier submission cuts the interval between first and tenth national submission from a median of years to weeks, and reduces sponsor regulatory operations cost per oncology product by at least a third.
Rationale
The gap between first approval and submission in most countries is driven by sponsors sequencing filings by market size, and by the cost of each regional dossier. If the marginal cost of submitting to an extra country is near zero, submissions happen sooner. Aviation and financial regulators already operate shared filing infrastructures.
What would test it
Have ICH commission a pilot in which three sponsors submit three new oncology products through a shared repository to five regulators simultaneously, measuring reformatting hours and question overlap against matched conventional submissions.
Maturity
speculative
Who has to act
regulator
Cost to try
Medium ($1M to $50M)
Years to first evidence
5
Bottlenecks it attacks
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.