# Manufacturing-change passport: one approved CMC change accepted everywhere in 30 days

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

## TL;DR

Changing how a cancer drug is made must be approved separately in over a hundred countries, which takes years and causes shortages. One approval should count for all.

## Summary

Post-approval chemistry, manufacturing and controls changes (new site, new supplier, process improvement) take three to five years to be approved worldwide because each country reviews them separately; manufacturers therefore delay improvements and keep obsolete processes running. ICH Q12 provides tools for managed change but adoption is uneven. The proposal is a reliance passport: a CMC change approved by any WHO-listed authority is deemed approved by participating regulators 30 days after notification unless they object with reasons.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Passport adoption cuts the time to global implementation of a CMC change for oncology medicines from a median above three years to under six months, and reduces the number of oncology drug shortages attributed to manufacturing changes.
- Rationale: CMC changes are assessed against the same pharmacopoeial and comparability standards everywhere; duplicate review adds time but not safety. Shortages of platinum chemotherapy in 2023 were prolonged by the inability to switch or add sites quickly.
- Proposed test: Pilot among Access Consortium and Orbis members on 50 CMC changes for oncology products; measure time to global implementation and any post-change quality defects against matched historical changes.
- Maturity: early-clinical
- Actor: regulator

## Sources

- ICH quality guidelines (Q12): https://www.ich.org/page/quality-guidelines

## Connected records

- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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