Mutual recognition of GMP inspections for cell, gene and radiopharmaceutical plants
Factories making living or radioactive cancer medicines are inspected separately by each country. Accepting each other's inspections would free up inspectors and speed supply.
The EU-US Mutual Recognition Agreement covers inspections of most human medicines but has been slow to extend to advanced therapy medicinal products and has no equivalent with Japan, China or India for these classes. Cell-therapy and radiopharmaceutical sites face repeated inspections by multiple agencies, each a multi-week interruption. The proposal is to extend PIC/S and MRA reliance explicitly to ATMP and radiopharmaceutical manufacturing, with a shared inspection schedule and a common inspection report template.
- 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.
Pages like this
not linked directly; found by shared links- IdeaComparability by design: a digital twin and sentinel panel for cell process changes
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaHarmonise Europe's hospital exemption for academic cell therapies, with one registry
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaA coordinated reserve and shared schedule for the world's medical isotope reactors
Shares Radioligand therapy (beta emitters), Manufacturing cost and time for living and radioactive medicines.
- IdeaManufacturing-change passport: one approved CMC change accepted everywhere in 30 days
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines.
- IdeaA neutral slot exchange so unused CAR-T manufacturing slots go to the next patient
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaPublic reference standards and potency assays for CAR-T so every lab measures alike
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaTwo-day CAR-T manufacture paired with rapid release tests that regulators accept
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaAn open interoperability standard for closed automated cell-processing machines
Shares Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.