All Journal articles – Page 9

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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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    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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    May 2022 – Contents

    May 2022  |  Volume 19  |  No.5

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    CMC considerations for US biosimilars development


    The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products. This pathway brought the hope of lower cost biologics, perhaps similar to what was accomplished by generics for small molecule drugs. Twelve years have now passed since the BPCI Act and experience continues to be gained with biosimilars development… 

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    A regulatory view on the change management process for medicinal products


    An effective change control process is a critical part of good manufacturing practice (GMP), during the post-approval phase of a medicinal product’s lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation (ICH) quality guidelines. The operational aspects of the change control process are explored and guidance is provided on how the strategic review of changes can avoid or minimise the regulatory impact.

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    Amgen’s experience of global expedited regulatory pathways in the development of sotorasib (Part 1)


    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. For 40 years, this condition had been considered undruggable. Sotorasib became the first approved targeted therapy for the treatment of adult patients, with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The approval was achieved in less than three years from first in human (FIH) exposure. This case study provides regulatory insights into the global expedited pathways and special designations, which were utilised during the development and marketing application review.

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    A review of paediatric development challenges, FDA collaboration and future trends


    Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...

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    The national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot


    Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...

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    Planning for the future: sustainable medical devices


    Pharmaceutical and medical device companies are increasingly looking at new ways to incorporate sustainability into their strategies in a bid to help the environment. While existing medical device standards do not address sustainability explicitly, ISO working groups and others are now considering sustainability as an important component of medical device development. The heavily regulated world of medical devices will likely see sustainability standards emerging in the next decade.

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    Electronic leaflet pilot in Belgium and Luxembourg hospitals


    The e-PIL Pilot was set-up in Belgium and Luxembourg with the objective to demonstrate the equivalence between the paper patient information leaflet and the electronic patient information leaflet in providing information on the safe and effective use of medicines in hospital setting. The first results of the Pilot are promising ...

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    Brexit: The regulatory landscape one year on


    A year since the UK departed from the EU, what has changed? The UK has started to depart from the EU in a number of different ways. This article will explore what has changed, how it came about and what to look out for as the relationship between the UK and EU, as well as the rest of the world, continues to evolve.

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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] 

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    March 2022 – Contents

    March 2022  |  Volume 19  |  No.3

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    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 ...

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    February 2022 – Contents

    February 2022  |  Volume 19  |  No.2

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    Selection and justification of regulatory starting materials


    A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.

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    June 2022 – Contents

    June 2022  |  Volume  19  |  No.6

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    April 2022 – Contents

    April 2022  |  Volume 19  |  No.4

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    January 2022 – Contents

    January 2022  |  Volume 19  |  No.1