All Regulatory Rapporteur articles in June 2022

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    Article

    Updates to quality legislation from the EMA

    2022-05-26T14:47:00Z

    Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.

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    Article

    Evolutions in patient healthcare at the MHRA

    2022-05-26T14:09:00Z

    Alison Cave, Chief Safety Officer at MHRA, discusses her role at the MHRA, current key objectives in the organisation and its future ambitions for improving patint healthcare. 

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    Article

    Exploring Amgen’s Project Orbis experience with sotorasib (Part 2)

    2022-05-26T13:32:00Z

    On 28 May 2021, sotorasib (LUMAKRAS™/LUMYKRAS®), a novel, first-in-class, inhibitor of the RAS GTPase family became the first drug to be approved by the US Food and Drug Administration (FDA) to target Kirsten rat sarcoma proto-oncogene (KRAS) G12C, a target that was considered undruggable for 40 years. Sotorasib is indicated ...

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    Article

    What can past decision-making data tell us about how the FDA will make future combination product categorisation decisions?

    2022-05-26T11:04:00Z

    In the US, combination products are categorised into drug/biologic or device regulatory schemes based on the primary mode of action (PMOA). The PMOA can be straightforward for certain combination products. It could be either a device action or a drug/biologic action. However, the determination of the PMOA for complex multimodal and novel combinations are more complex. This article will review a case of a borderline drug/device combination, with a disputed PMOA, and apply a simple regulatory framework to determine the appropriate PMOA. The article details how the FDA determines the PMOA for combination products and the importance of early determination.

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    Article

    Medical device standards update

    2022-05-25T10:27:00Z

    This edition of our regular column updates the progress of applicable horizontal standards to February 2022.

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    Editorial

    June 2022 Editorial: How regulators are navigating the evolving pharmacovigilance landscape

    2022-05-20T15:51:00Z

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

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    Article

    10 years of pharmacovigilance legislation: the perspective of a national agency

    2022-05-20T15:40:00Z

    In 2012, the new pharmacovigilance legislation came into force, which established a uniform standard for the safety monitoring of medicines in Europe. These new legal requirements resulted in impactful changes, including the creation of a further scientific committee at the European Medicines Agency’s (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC). It also resulted in a new framework for signal management, the establishment of a periodic safety update report (PSUR) single assessment and additional requirements for risk management plans (RMPs). This article reflects upon the past 10 years’ experience, including the recent pandemic. Suggestions are made on areas where the legal framework may need to be further adapted to a changing regulatory environment.