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News & Press: Regulatory Updates

PHSS Regulatory Update May 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 2013


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, US Canadian, WHO and PIC/S regulatory authorities.

The topics covered in this edition of the ―Update include:


· Guideline on the use of phthalates as excipients in human medicinal products

· Australia listed as equivalent for API imported into the EU

· EDQM provides an update on its eTACT traceability project,for medicines

· MHRA -New requirements for active substances imported into the European Economic Area

· MHRA policy for handling conflicts of interest


· USP General Chapters <229.7> Gaseous Sterilization

· FDA Launches Pilot Project for Electronic Submission of Field Alert Reports



· New API GMP regulations


· New PIC/s membership applications


· Proposed revision - GMP appendix 7: non-sterile process validation


· Diane 35 and its generics – update


· What you need to know about biosimilar medicinal products

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