Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Regulatory Updates

PHSS June 2019 Regulatory Update:EP 10th Edition 10.0-10.2; EDQM inspections

03 June 2019   (0 Comments)
Posted by: Tamsin Marshall
Share |

PHSS June 2019 Regulatory Update

 

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 Australian and USA regulatory authorities.

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

 

Europe

  • EMA facilitates early engagement with medicine developers to combat antimicrobial resistance

    European Pharmacopeia 10th Edition 10.0-10.2

  • EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018

  • What does qualification of suppliers mean to you? Risks to patients and to your business

 

USA

 

  • Considerations in demonstrating interchangeability with a reference product
  • Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
  • Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics
  • Framework for the Regulation of Regenerative Medicine Products

International

Australia

  • Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework

 

Canada

  • Changes regulations to help prevent illegal production and trafficking of controlled substances

PIC/s

  • PIC/S meeting April 2019 (Geneva Switzerland)

WHO

  • The 53rd ECSPP report (WHO Technical Report Series, No. 1019) now available 

Products

  • EU withdrawal of marketing authorisations for fenspiride medicines
  • EU Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs

Membership Software Powered by YourMembership  ::  Legal