Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

March 2022  |  Vol. 19  |  No.3

 

EDITORIAL

The UK and Brexit: innovation and optimism in uncertain times

Ever since the UK held its EU membership referendum in June 2016 with the outcome that we now know of so well, every industry with close ties to Europe has been struggling to cope with the resulting uncertainty and the movement of goalposts.

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 By Sobhey Nassar and Jillian Stewart

 

FOCUS

Brexit: regulatory and supply chain considerations

Following its exit from the EU, the UK adopted an independent regulatory framework with the MHRA positioned as the standalone regulator for medicines and medical devices within the UK jurisdiction. This article reviews the key changes relating to medicinal product licensing and supply chain arrangements following the UK’s exit from the EU.

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 By Graham Donaldson and Regina Dawkins

 

FOCUS

Pharmacovigilance regulations post-Brexit

The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements.

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 By Mary Stapleton

 

FOCUS

The impact of the Northern Ireland Protocol on human medicines

Since the UK’s exit from the EU, the pharmaceutical industry has sought guidance on how this would impact the registration and supply of medicines, both in the UK and the EU. This article aims to provide an overview of the key areas of medicines regulation impacted by the protocol, as well as current guidance that ensures the supply of registered human medicines to the Northern Ireland market.

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 By Janet Fitzgerald

 

FOCUS

Gavin Hall, Interim Director of Authorisations at the Veterinary Medicines Directorate, discusses the agency’s drive to harmonise scientific guidelines and its readiness to be flexible with regulatory frameworks following Brexit.

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 By Pascale Canning

 

FOCUS

Regulating medicines in a surge of change

Steve Hoare, Quality Regulatory Science and Safety Policy Director at The Association of the British Pharmaceutical Industry (ABPI), discusses the impact of Brexit and COVID-19 on the pharmaceutical industry and how industry continue to evolve.

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 By Victoria Goff

 

STANDALONE

A review of Project Orbis: an initiative enabling faster access to cancer therapies

Project Orbis was initiated on 17 September 2019 by the US FDA to provide a framework for the concurrent submission and review of innovative oncology products among international regulatory authorities. This article discusses the first year of Project Orbis.

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 By Leah Kleylein

 

STANDALONE

Navigating the regulatory landscape for regenerative medicines in Japan

This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines, across three ICH territories: the EU, the US and Japan. It focuses on the regulation of regenerative medicines in Japan, highlighting important milestones in the history of approval of regenerative medicines.

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By Harriet Edwards

 

STANDALONE

Hype over hemp as a veterinary feed additive

There has been much talk about the positive effects of CBD for human health, and there is some suggestion this could apply to animals. Is this desirable – or even legally feasible? Using Germany as a case study, this article examines whether and under what conditions CBD could be marketed for animal use.

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By Thomas Bruggmann

 

 

 

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