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News & Press: Regulatory Updates

PHSS May 2017 Regulatory Update ; Consequences of Brexit; EU ATMP GMP; Water for Pharm Use

08 May 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS May Regulatory Update 2017

 

This month's update includes a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU and USA regulatory authorities. It is worth mentioning that in recent editions of The Update a number of items have originated in the MHRA Blog. This is a very useful source of reference to MHRA’s current thinking and practices. 

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

 

Europe

  • EMA and heads of national competent authorities discuss consequences of Brexit

  •  Report from the EMA -FDA QbD pilot program

  •  Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use

  •  Test for Abnormal Toxicity: towards possible deletion from the European Pharmacopoeia

  •  Top 10 deficiencies -New Applications for Certificates of Suitability (CEP) for chemical purity

  •  MHRA GMP Inspection Deficiency Data Trend 2016

  •  Computer System Validation – GCP

USA

 

  • Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles

  •  Providing Regulatory Submissions in Electronic Format.

     

International

PIC/s

  •  Reaffirmed stance on proposed EU ATMP GMP Guidelines and highlights gaps relating to patient safety

Documents

  •  ABPI manifesto

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