All Regulatory Rapporteur articles in March 2022

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    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…[1],[2] 

  • medicines

    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.

  • cancer therapy

    A review of Project Orbis: An initiative enabling faster patient 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. The focus of the initiative is on high impact cancer treatments targeting unmet needs or providing significant benefit over existing ...

  • brexit

    March 2022 Editorial: The UK and Brexit – innovation and optimism in uncertain times


    Although there is still alignment with the EU, the regulatory strategy for new submissions and variations has changed and we must adapt to such changes. No doubt further changes are on the way, which we must be ready for again.

  • brexit 2

    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. In addition, the publication of the Northern Ireland Protocol has added additional complexities, with a major impact on the ...

  • Brexit supply chain

    Brexit − Regulatory and supply chain considerations


    The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...

  • hemp

    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, we examine whether – and under what conditions – CBD could be ...

  • post brexit

    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. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...

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    A strong advocate for global harmonisation in animal health


    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.