Regulatory
Rapporteur
Write to the Editor at publications@topra.org
December 2024 | Vol. 21 | No. 11
EDITORIAL
North America: Navigating key regulatory updates
The December issue of Regulatory Rapporteur focuses on North America. The pace of regulatory change has surged in recent years, due to increased innovation and available data and this has made it hard to keep abreast of key updates and programmes. The articles in this issue aim to help regulatory affairs professionals navigate new guidance and requirements.
By Leah R. Kleylein and Nancy Pire-Smerkanich
FOCUS
Notable US Food and Drug Administration pilot programmes
At any given time, the US Food and Drug Administration (FDA) can have dozens of ongoing pilot programmes involving single or multiple Centers and it can be challenging to track the existence and status of these if they are not directly related to therapeutic or technical synergies within a sponsor company. This article reviews four of the FDA’s recent pilots which span the areas of study data technology, guidance comprehension, rare diseases and medical devices.
By Leah R. Kleylein
FOCUS
Health Canada: Points to consider when preparing quality and new substance notification documentation for investigational medicinal products
Health Canada, the Canadian regulatory authority for medicinal products, does not currently have a dedicated quality overall summary (QoS) template for biopharmaceuticals, advanced therapy medicinal products, genetically modified organisms and vaccines. Sponsors are also often confused by the new substance notification requirements for these investigational medicinal products (IMPs) containing a drug substance classed as a chemical or a biochemical. This article provides helpful guidance on QoS requirements for these biological IMPs.
By John Watkins and Morgane Lejeune
FOCUS
Shedding light on essential drug delivery outputs
In June 2024, the FDA published draft guidance on ‘Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products’. This aims to clarify earlier communications on the performance requirements for drug-led (or biological product-led) drug-device combination products and eliminates the term ‘essential performance requirement’. This article gives a comprehensive analysis of this new draft legislation and what it hopes to achieve, and addresses areas of confusion that industry is facing.
By Susan Neadle
STANDALONE
Transitioning to the Clinical Trials Regulation: The Roche experience
All clinical trials authorised under the Clinical Trials Directive with at least one active site in the European Economic Area on 30 January 2025 must complete the transition to the Clinical Trials Regulation (EU) 536/2014 (CTR)1 within the CTR transition period of three years ending on 31 January 2025. This article outlines the experiences of Roche in switching a portfolio of approximately 150 ongoing studies within the transition period, its insights into navigating this complex process and its reflections on the implementation of the CTR and how it can be a catalyst for Europe’s attractiveness for research and development in an increasingly competitive global environment.
By Valentina Geisseler-Homann, Natalia Lugli, Jo Molloy and Marco Rafael
STANDALONE
Medical device standards update
This edition of our regular column updates the progress of applicable standards for medical devices and in vitro diagnostic devices up to October 2024.
By Charlotte Holleran
STANDALONE
Early development of vaccines and prophylactics in infectious diseases: A post-pandemic regulatory overview
During the COVID-19 pandemic, an unprecedented level of regulatory flexibility accelerated the authorisation of COVID-19 products and this led to the European Medicines Agency and the FDA developing new guidance on COVID-19 prophylactics and therapeutics and updates on vaccine development. This article discusses the current regulatory status and its impact on the early development of vaccines and prophylactic treatments for infectious diseases.
By Bruno Speder and Robin Rogiers
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