• October 2023 – Contents

  • Veterinary medicines: the challenges of new regulation

  • Transition to the new QRD template for veterinary medicines: challenges and opportunities

  • Autogenous vaccines under Regulation (EU) 2019/6

  • Prequalification of veterinary vaccines and medicines

  • EMA activities related to antiparasitic veterinary medicinal products

  • Optimal materials selection in medical device development – a proactive biocompatibility approach

FDA committee finds OTC decongestants
to be ‘ineffective’

An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.

EMA future ‘VetMeds’ for healthy animals and humans; seminar

In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.

Covid vaccines ‘not to be offered routinely’ to healthy under-65s

Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.

UK doubles capacity for certification of medical devices

TÜV SÜD, Intertek, and TÜV Rheinland UK have been designated as UK Approved Bodies to assess and certify general medical devices.

  • September 2023 – Contents

  • The worldwide web of regulation

  • Q&A:
    Navigating the
    pharmaceutical supply chain

  • Navigating the global supply of starting materials for cell-based therapies

  • Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry

  • Biosimilars CMC development considerations from the sponsor perspective

  • Warning letters for direct-to-consumer advertising: a five-year retrospective analysis


RegRapPod − September 2023


Vol.20 #8: In the September 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Vickie Goff about globalisation and the supply chain.

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  • European Parliament gives first stage approval for revised EMA fees

  • Change Across the Medical Device Landscape

  • Northern Ireland deal permits GB medicines but not medical devices

  • UK set to accept CE mark for medical devices until 2028

  • US Food and Drug Law Institute Annual Conference