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Regulatory
Rapporteur

Write to the Editor at publications@topra.org

November 2023 | Vol. 20 | No.10

EDITORIAL

Welcoming continental
convergence in regulation

The focus of this issue is North America, but it’s difficult to focus on just one region or one regulatory authority in today’s environment. There is constant news of new collaborations, new pilots, new memberships where multiple regulatory authorities are working together to improve the quality and speed − in a responsible way − of product approvals.

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By Leah Kleylein

FOCUS

A harmonised approach to clinical data standards

David Evans, President and CEO of CDISC, discusses his role at the helm of the standards development organisation and the ways it is supporting the advancement of global data standards in clinical research.

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By Leah Kleylein and David Evans

FOCUS

Controlled substance development − past, present and future

Controlled substances have been subject to strict regulation which has made it difficult for sponsors to conduct clinical trials or marketing them. This article provides historical context on approaches to controlled substances in Europe and the US.

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By John Joines, Sean Schofield, Radosveta Minkova and Desislava Dimitrova

FOCUS

Overview of the importation strategy from an FDA perspective − PLAIR vs FTZ

Importation strategies are crucial when anticipating a product approval. This article provides perspective on two approaches, PLAIR and FTZ, that can be applied to importing unapproved products into the US.

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By Manan Shah

FOCUS

Transitioning from paper to electronic IFU for EU MDR 2017/745

IInstructions for use (IFU) in electronic format can provide benefits for healthcare professionals. This article discusses the challenges and opportunities of transitioning from paper to electronic instructions for use for various classes of medical devices.

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By Shikha Malik

FOCUS

Access Consortium: in the current submission transmission ecosystem

The Access Consortium is a coalition of medium-sized regulatory authorities that work together to promote collaboration and harmonisation of regulation. This article explores the Consortium and recommendations for using its pathway.

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By Solange Corriol Rohou, David S.Ross and Amanda Tombs

STANDALONE

Medical device standards update

Regulatory Rapporteur’s latest edition of medical device standards provides an update on the progress of applicable standards for medical devices and in vitro diagnostic devices.

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By Mehryar Behizad