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    Advancing global
    healthcare together


    An annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products

  • North America

    Editorial - November 2023


  • October-2023-Cover-Cows-02

    Veterinary medicines: the challenges of new regulation


    Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...

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    The worldwide web of regulation


    In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...

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    Equal access to medicines:
    finding the balance

    Regulatory Rapporteur July/August 2023 | Volume 20 | No.7 This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing ...

  • RR-JUNE-2023-COVER

    Clinical trials:
    Ethical, ecological
    and economic change


    In the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?

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    Mind the gap:
    Innovation vs
    regulation of ATMPs


    Technology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.

  • Latin America

    The region walking the regulatory walk


    Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.

  • Setting the right standards

    Setting the right standards


    The theme of this issue is global standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.

  • The need for robust quality management

    The need for robust quality management


    It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...

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    Patient evidence and engagement


    Don’t we in Life Sciences excel at generating abbreviations and acronyms? For example, do you know your COA from your PED or PPI? Or PEE from PRO? If you don’t, an explanation will be forthcoming in this edition of the Regulatory Rapporteur.

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


    It is the most wonderful time of the year – yes, that is Symposium issue time – and the Regulatory Rapporteur editorial team never want to disappoint! The TOPRA Symposium is one of the major annual events for those working in regulatory affairs, and the 2022 Symposium – hosted in ...

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    Adapting, transforming and innovating


    For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...

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    Great expectations for medical technologies


    Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...

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    Regulatory operations: Evolution and revolution


     ‘Operations’ does not quite do justice to the critical role that these individuals play in the global team

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    A new era of digital and data-driven innovations


    Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working

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    How regulators are navigating the evolving pharmacovigilance landscape


    In the area of regulatory affairs and pharmacovigilance (PV), we are constantly confronted with new laws, guidelines and other regulations

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    CMC acceleration is driven by a scientific revolution


    The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals

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    The future of pharmaceuticals is green


    The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years

  • brexit

    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.