All Regulatory Rapporteur articles in June 2022

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    Updates to quality legislation from the EMA


    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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    Evolutions in patient healthcare at MHRA


    Chief Safety Officer, Alison Cave discusses her role at the MHRA, key objectives and ambitions for the regulator.

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


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


    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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    Medical device standards update: February 2022


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

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


    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.

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    June 2022 – Contents

    June 2022  |  Volume  19  |  No.6