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Second Time Around: EU GMP Guideline For ATMPs Out For Consultation Again

Executive Summary

The European Commission's latest draft guideline on GMP requirements for ATMPs might make things easier for ATMP producers who are not engaged in mainstream pharmaceutical production.

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EU biopharmaceutical industry group EBE says it is awaiting keenly the publication of good manufacturing practice guide for advanced therapy medicinal products, after learning that the European Commission is making changes to address concerns it had over the appropriate format of the document.

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After holding two rounds of public consultation on its proposals for good manufacturing practice requirements for advanced therapy medicinal products, the European Commission has still not been able to address stakeholder concerns regarding the appropriate format of this eagerly-awaited draft guideline.

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Juno Therapeutics and bluebird bio are the latest companies to get accepted on the European Medicines Agency’s PRIME (priority medicines) scheme with their advanced therapy medicinal products. ATMPs are now the most common type of product on the scheme, and help is coming for developers trying to navigate Europe’s notoriously challenging ATMP framework.

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