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News & Press: Regulatory Updates

PHSS Regulatory Update September 2012

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update September 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 and Indian regulatory authorities.

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


· EudraLex Vol 4 Ch 1 Pharmaceutical Quality System

· EudraLexVol 4 Annex 2 - Biologicals

· Delegated Act - Medicinal Products introduced in the Union but not intended to be placed on the Market

· Is a certificate of suitability equivalent to a GMP certificate?

· 11TH Symposium on pharmaceutical reference Standards

· Company authorisations issued without expiry date

· New authoritative guide to Good Clinical Practice


· Can you tell us about FDAs position on biosimilars?

· Impact of Severe Weather Conditions on Biological Products

· Quality by Design for ANDAs: An Example for Modified Release Dosage Forms

· Draft Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products


India / WHO

· International consultation on developing blueprint to combat spurious drugs with use of technology


· Waste gutter oil used to manufacture 7-ACA

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