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News & Press: Regulatory Updates

PHSS Regulatory Update Feb 2016: Changes in CEP; Data Integrity; Revised Measures for CJD

15 February 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS February Regulatory Update 2016 

 

On this months PHSS Regulatory Update reported issues have come from the EU and USA regulatory authorities.

The topics covered in this edition of the “Update” include

 

Europe

  • Revised Q&A on QP declaration (Co-ordination Group for Mutual Recognition and Decentralised Procedures – human CMDh)
  • Changes in CEP named contact details to be notified to EDQM

USA

  • New requirement for electronic submission of drug master files (DMFs)
  • Revised preventive measures to reduce the possible risk of transmission of CJD and variant CJD by blood and blood products
  • Guidance documents CBER is planning to publish during calendar year 2016

International

Japan

  • Data Integrity

Products

  • Abbott's compounding pharmacy issues voluntary recalls of all lots of unexpired sterile due to lack of sterility assurance
  • USFDA approves first drug to treat a rare enzyme disorder in paediatric and adult patients

 


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