All Journal articles – Page 8

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    EU expert panels for high-risk devices - another level of review?

    2022-09-16T09:25:00Z

    The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both ...

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    Journal

    The new UK MDR - a great start to a long road ahead

    2022-09-16T09:25:00Z

    On 29 March 2017, the UK invoked Article 50 of the Treaty on European Union (EU)[1] and began the withdrawal process from the EU. Despite the UK’s departure from the EU on 31 January 2020, EU legislation continues to apply in UK domestic law. This means that, for the medical ...

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  • Harmonising-HERO
    Journal

    Harmonising regulation of medicinal allergen products throughout the European Union – the historic situation and subsequent CMDh guidance

    2022-08-22T00:01:00Z

    Allergen products in the EU are defined as goods ‘intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent’. Historically, allergens were authorised under the national frameworks of member states (MS) with some legislation pre-dating the Treaty of Rome in 1957. This led to regulatory problems, such as pharmacovigilance monitoring standards. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) addressed these authorisation issues and published a document on recommendations to common regulatory approaches for medicinal allergen products. This article provides an overview of the CMDh guidance, including a summary of some of the responses received during its consultation phase.

  • What are the key challenges for industry in the Rx-to-OTC switch process?
    Journal

    EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome? Part 2

    2022-08-22T00:01:00Z

    Rx to over the counter (OTC) switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or general shop without a prescription. This research investigates the challenges the pharmaceutical industry has faced 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.

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    Journal

    Inclusion of older people in drug development and clinical trials: Part 1

    2022-08-22T00:01:00Z

    As the global population ages, older people will increasingly become the main users of medication. Much work has already been done by regulatory authorities to review legislation, leading to the 2013 publication of the EMA’s Geriatric Medicines Strategy. It reported, however, that many clinical trials still did not include a representative number of older people – aged 65 and over – despite the drugs in development were most likely to be used by this cohort. This two-article series will analyse if the publication of ICH E7 Q&A influenced the number of older people included in clinical trials. Furthermore, a qualitative questionnaire assessed the extent to which clinical trials are designed to adequately represent older people. In part one, I will focus on the legislative framework governing drug development for older patients, and the sub-classifications of age groups.

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    July/August 2022 – Contents

    July/August 2022  |  Volume  19  |  No.7

  • Journal

    Future Focus Topics

    2024 March Asia-Pacific − Regional Focus April Data May Advanced Therapies June Access to Medicines July/August Green Pharma/Sustainibility September Nutraceuticals & borderline products October Chemistry, manufacturing and controls November TOPRA Annual Symposium 2024 − Rotterdam December North America ...

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    FDA meetings: How to hold a successful meeting across the drug development lifecycle

    2022-06-24T16:13:00Z

    This continuing professional development supplement discusses the available meeting options for products regulated by CDER and CBER, which should help the reader select the appropriate avenue to receive the Agency’s advice and develop a viable regulatory interactions strategy.

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    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 ...

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    Journal

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

    2022-06-23T10:39:00Z

    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.

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    Journal

    Antibiotics in biopharmaceutical production

    2022-06-23T09:46:00Z

    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 ...

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    Journal

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

    2022-06-22T14:53:00Z

    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.

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    Journal

    Digital and data-driven: information management at the EMA

    2022-06-22T09:58:00Z

    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

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    Regulatory complexities and challenges of biosimilars

    2022-06-15T10:09:00Z

    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.

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    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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    Evolutions in patient healthcare at MHRA

    2022-05-26T14:09:00Z

    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)

    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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    Journal

    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.