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Concerns Over Format Of EU GMP Guideline For ATMPs Finally Resolved; Publication Due

 
• By Vibha Sharma

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.

The European Commission's much-awaited guideline on good manufacturing practices (GMP) for advanced therapy medicinal products (ATMPs) is likely to be published in the first half of 2017 as a stand-alone document. The document has been in the making for over a year and has undergone two rounds of stakeholder consultation.

Initial concerns that the industry had regarding the format of the final document – i.e., whether it should be a...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
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