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News & Press: Regulatory Updates

PHSS Nov 2016 Reg Update: List of Withdrawn drugs; Certificate of non-compliance issued;Concept pape

07 November 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS November Regulatory Update 2016

 

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU and USA regulatory authorities.

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

 

Europe

·         Annual report of the GMP & GDP Inspectors Working Group 2015

·         Concept paper on GMP and MA Holders

·         First comprehensive overview of global initiatives on medicine regulation

·         Certificate of non Compliance - Nandu Chemicals Industries.

·       Guideline for use of a CEP in another CEP application

·       MHRA Blood Forum

 

USA

  • Product-specific recommendations for generic drug development
  • ANDA Submissions – Prior Approval Supplements Under GDUFA
  •  Tropical disease priority review vouchers
  •  List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness
  •  USP proposed changes

 

Documents

·         €10.2 billion lost every year across the EU due to fake medicines

·         Ph. Eur. 9th Edition

·         USFDA/ CDER Report on Drug Safety Priorities

Products

·         Risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C


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