Regulators Call for More Harmonization On Ultra-Rare ATMPs
Early discussions between companies and multiple regulators could drive greater alignment among jurisdictions.
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More pollical support from the National Health Service and health ministers is needed to ensure the UK’s future as a desirable launch market.
The cancer drug is also to undergo an accelerated assessment by the European Medicines Agency.
The Alliance For Regenerative Medicines is calling for advanced therapies to be given greater priority where joint clinical assessments are concerned.