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News & Press: Regulatory Updates

PHSS October 2020 Regulatory Update: MHRA EU Exit & Post Transition guidance webinar; Blog GMDP

05 October 2020   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 2020 available for download for members! Login to view

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 Australian EU, UK, PIC/s and USA regulatory authorities.
The topics covered in this edition of the “Update” include

Europe
  • How incidents with medicines are managed in the EU – a ten-year analysis
  • Big Data - HMA/EMA Big Data Steering Group
  • Q&A: Type II variations – veterinary
  • Q&A: Extension applications
  • Public consultation on the CEP of the future
UK
  • EU Exit and Post Transition guidance webinar series
  • Blog - Investigations in the GMDP environment
International
USA

  • ICH M7 Guideline: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk- Q&A
  • Control of nitrosamine impurities in human drugs
  • Resuming Normal Drug and Biologics Manufacturing During the COVID-19 Public Health Emergency
  • Draft guidance - Geriatric information in human prescription drug and biological product labeling
  • Health Secretary Azar Asserts Authority Over F.D.A.
  • Failure to respond to an ANDA complete response letter within the regulatory timeframe
  • ANDA Submissions – Amendments and requests for final approval to tentatively approved ANDAS
Australia
  • New Early Scientific Advice service to support medicine registrations
  • Information for medicine advertisers: Additional allergen warnings effective 1 September 2020
  • Consultation: Compounded medicines and good manufacturing practice (GMP)
PIC/s
  • 2020 PIC/S virtual Seminar
Products
  • Update on the review by EDQM of the CEP application regarding an impurity in the active substance paracetamol.

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