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PHSS Apr 2017 Regulatory Update ; EU and US MRA - regulators agree on mutual recog. of inspections

10 April 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS April 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

  • EU and US MRA - regulators agree on mutual recognition of inspections of medicines manufacturers
  • Q&A implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits
  • Biosimilars: Ph. Eur. monographs are flexible and evolving standards
  • Management of applications for new CEPs and revisions/renewals of CEPs
  • CMDH Q & A- QP declaration
  • MHRA GDP Symposium 2016
  • Import of Centrally Authorised medicines for supply to other Member States where the medicine is not yet available in the correct pack
  • Too much pressure: a behavioural approach to Data Integrity (Part 2)

USA

 

  • FAQ-The USA / EU MRA
  • Guidance for industry- Hypertension indication: drug labeling for cardiovascular outcome claims
  • Requirements for transactions with first responders under section 582 of the federal FD&C act 

Products

  • EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

Conferences

  • Challenges in Sterile Product Manufacture – clarity of GMP
  • EDQM Symposium on Microbiology planned for October 2017
  • BIA / MHRA joint conference “Innovation in life sciences in a changing and dynamic environment”

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