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News & Press: Regulatory Updates

PHSS Dec Reg Update: Industry Stakeholder meeting on Brexit report; Dose Escalation; USA / EU MRA u

03 December 2018  
Posted by: Tamsin Marshall
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PHSS Regulatory Update Dec 2018

 

During the last 4 weeks there have been several developments in the regulation of the pharmaceutical industry. This month reported issues have come from the Australian, EU, US and PIC/s regulatory authorities.

Once again, we report on a USA compounding pharmacy making and releasing products where there is a lack of sterility assurance. The company also is said to have ignored FDA advice on more than one occasion.

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

 

Europe

  • Report of Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

  • Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations

  • Dose Escalation – is it GCP compliant?

  • Relevant training for GCP laboratory staff

USA 

 

  • USA / EU MRA update

  • FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs

  • Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products

  • FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions

  • Measles vaccine-Option to lower lot release specification for required measles antibody potency testing


International

 

Australia

 

  •  Inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement.

 

PIC/s

  • Revised draft PIC/s guidance on good practices for data management and integrity in regulated GMP/GDP environments

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