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News & Press: Regulatory Updates

PHSS Regulatory Update August 2012

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update August 2012


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, USA, Brazil and China.

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


· Updated CEP application forms

· EDQM annual report

· Guideline on Active Substance Master File (ASMF) procedure

· EU incident management plan for human medicines

· Leaflet on importing APIs into the EC

· Recommendations to deal with sterility assurance concerns for DepoCyte

· EU-wide control on the export of certain drugs usable in execution by lethal injection.

· Simplified UK medicines regulations come into force Aug 14


· FDA Safety & innovation Act (FDASIA)



· Revised deadline for comment – Excipient GMP


· Final pharmaceutical excipients guideline

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