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News & Press: Regulatory Updates

PHSS Oct 2019 Regulatory Update: Ranitidine containing medicinal products; Name change of liposomal

07 October 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 2019  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, PIC/S and WHO regulatory authorities.

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



  • Ranitidine containing medicinal products

  •  Advice to companies on steps to take to avoid nitrosamines in human medicines

  • Change of name of liposomal medicines at high risk of medication errors (update)

  • Implementation of the new Veterinary Medicines Regulation

  • MHRA Blog - Supply chain security: part 1 - introduction


  • NMDA impurity in certain ranitidine products 

  • Wholesale distributor verification requirement for saleable returned drug product

  • Bringing remaining approved OTC medically important antimicrobial drugs used for animals under veterinary oversight

  • Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

  • TCPro simulates immune system response to biotherapeutic drugs

  • Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Q&A



  • Updated Guidelines for making an offer of enforceable undertaking to the TGA

  •  TGA business plan 2019-20


  • Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)


  • Proposal to discontinue the test for undue toxicity (chapter 3.7) in the international pharmacopoeia 


  • USFDA approves first live, non-replicating vaccine to prevent smallpox & monkeypox

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