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News & Press: Regulatory Updates

PHSS Dec 2017 Reg Update: Practical Guidance for Brexit; EMA relocation; ATMP GMP

13 December 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update December 2017


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 China,the EU, Swiss, USA & PIC/s regulatory authorities

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



  • Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
  • Safety features for medicinal products for human use
  • GMP guidelines specific to Advanced Therapy Medicinal Products (ATMPs)
  • Q&A on the impact of Mutual Recognition Agreement between the EU and the USA States as of 1 Nov 2017
  • New EudraVigilance system goes live
  • EMA gets ready for relocation decision
  •  Improving the product information for EU medicines
  • EMA encourages companies to submit type I variations for 2017 by 30 November
  • Towards a single development programme for new antibiotics in EU, Japan and US
  • Improving the availability of vaccines for animals within the EU


  • Formal dispute resolution: sponsor appeals above the division level
  • Recommended statement for OTC Aspirin-containing drug products labeled with cardiovascular related imagery
  • Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
  • FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria
  • Use of a DMF for Shared System REMS Submissions
  • Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
  • ANDAs: pre-submission of facility information related to prioritized generic drug applications
  • Controlled correspondence related to generic drug development
  • International
  • Australia
  • Regulation of autologous cell and tissue products

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