Manufacturing-change passport: one approved CMC change accepted everywhere in 30 days
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.
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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
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