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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.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.