This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Regulatory Updates

PHSS Sept 2020 Regulatory Update: New ref stnds/replace batches; Nitrosamines risk assessment

04 September 2020  
Posted by: Tamsin Marshall
Share |

PHSS Regulatory Update September 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 Australian, EU, UK and USA regulatory authorities.
The topics covered in this edition of the “Update” include:

  • New reference standards / replacement batches.
  • Nitrosamines risk assessment: update for CEP holders
  • Nitrosamine impurities in human medicinal products
  • Post-authorisation procedural advice for users of the centralised procedure
  • Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with Pas
  • Big data


  • Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines
  • Cross Contamination Control in Shared Facilities and Equipment



  • Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency - Q&A.
  • Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)
  • Marketing status notifications under section 506i of the Federal Food, Drug, and Cosmetic Act (FD&C act)


Therapeutic Goods Administration (TGA) 

  • TGA business plan 2020/2021
  • Disinfectants: FAQ for new sponsors
  • Faecal microbiota transplant (FMT) products regulation
  • Azerbaijan applies for pre-accession


  • Ranitidine containing products

Membership Software Powered by YourMembership  ::  Legal