All Journal articles – Page 9

  • Journal

    Privacy Policy

    All registered users and members Regulatory Rapporteur is published and wholly-owned by TOPRA (The Organisation for Professionals in Regulatory Affairs). The peer-reviewed journal content in this website is published 11 times per year and is only made available to TOPRA members. As a registered reader we will send you ...

  • AdobeStock_278890190

    One year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products


    Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination.

  • AdobeStock_410157798 (1)

    Antibiotics in biopharmaceutical production


    As per the WHO, antimicrobial resistance (AMR) is a global health threat and a complex problem that requires a united multisectoral approach. In the interest of patients and environmental safety, regulators around the globe are discouraging the use of antibiotics in all areas of their utilisation ie, not only at ...

  • AdobeStock_180072866

    Part 1: EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome?


    Rx to OTC switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or shop without a prescription. This research investigated the challenges faced by the pharmaceutical industry with this process in the European Union and proposes where improvements could be made. It is important for consumers to have direct access to medicines without a prescription as this allows time for doctors to focus on more urgent care needs. This emphasis on consumer “self-care” is even more important now, during a pandemic, when face-to- face consultations with doctors have reduced.

  • AdobeStock_297198041

    Digital and data-driven: information management at the EMA


    Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for information management legislation

  • AdobeStock_296252792

    Regulatory complexities and challenges of biosimilars


    This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.

  • AdobeStock_151718711

    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.

  • AdobeStock_228931204

    Evolutions in patient healthcare at MHRA


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

  • AdobeStock_286032180

    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 ...

  • AdobeStock_474265160

    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.

  • AdobeStock_284766280

    Medical device standards update: February 2022


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

  • AdobeStock_303039330

    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.

  • AdobeStock_281211016

    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… 

  • AdobeStock_244609855

    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.

  • AdobeStock_282628451-min

    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.

  • paediatric

    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 ...

  • ipad doctor

    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 ...

  • epipen

    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.

  • AdobeStock_294542021

    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 ...

  • AdobeStock_229155404 (1) (1)

    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.