• May 2023 – Contents

  • Mind the gap:
    Innovation vs
    regulation of ATMPs

  • G-E-T-ting there – how gene editing technologies could change more than genes

  • Alternatives to animal testing
    in the development of ATMPs

  • Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR

  • Ensuring promotional
    materials’ compliance
    in the EU

  • Regulatory guidelines for
    nutraceuticals in India


Novel gene editing method “roughly threefold” better

Researchers from the University of California Santa Barbara (UCSB) have found two ways to boost the capabilities of CRISPR/Cas9.



Regulating Vaxzevria:
The world’s first COVID-19 vaccine

Vol. 20 #4
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod  is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria.

  • Mind the gap:
    Innovation vs
    regulation of ATMPs

  • The region walking the regulatory walk

  • Setting the right standards

  • The need for robust quality management

  • Patient evidence and engagement

  • Waltzing into change in Vienna:
    The regulatory future comes into focus

  • Adapting, transforming and innovating

UK set to accept CE mark for medical devices until 2028

The MHRA has confirmed an extension to certain CE-marked medical devices being placed on the GB market until June 2028

Source:  MHRA