{"entity":{"id":"idea-reg-manufacturing-change-passport","kind":"idea","name":"Manufacturing-change passport: one approved CMC change accepted everywhere in 30 days","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"ICH quality guidelines (Q12)","url":"https://www.ich.org/page/quality-guidelines"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":["carboplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-manufacturing-cell-therapy"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"small","horizonYears":3},"route":"/ideas/idea-reg-manufacturing-change-passport/","neighbours":{"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}