All Journal articles – Page 9

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    Journal

    VM4: Regulatory update and perspectives: Variations, packaging and labelling, pharmacovigilance

    2022-12-05T00:02:00Z

    Industry is navigating through complex new rules and opportunities for variations and will require continued cooperation. The year 2023 is expected to show the benefits of the revised pharmacovigilance procedures in practice.

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    Journal

    Breakthrough therapy designation: From serious diseases to opioid crisis prevention

    2022-10-31T14:41:00Z

    Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...

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    Journal

    The worldwide acceptance of non-legalised eCPPs

    2022-10-31T14:41:00Z

    The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...

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    Journal

    Medical device standards update: September 2022

    2022-10-31T14:41:00Z

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

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    Journal

    The power of collaboration

    2022-10-31T14:40:00Z

    Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.

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    Journal

    US FDA CDER and CBER guidance of interest

    2022-10-31T14:40:00Z

    The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...

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    Journal

    The health economics profile of new pharmaceuticals

    2022-09-16T09:26:00Z

    The current article discusses elements of the health economics profile of new pharmaceuticals, specifically looking at the challenges of providing a healthcare system, the concepts around the provision of value-based healthcare systems and calculating the cost-effectiveness of new medicines. A quality-adjusted life year (QALY) is a concept used in health ...

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    Journal

    Navigating the MDR’s heightened surveillance and performance requirements

    2022-09-16T09:25:00Z

    Substantial changes to post-market surveillance, post-market clinical follow-up and the new requirement to include a summary of safety and clinical performance, have all placed greater obligations on medical device manufacturers. The changes introduced by the Medical Device Regulation (MDR), have the overarching objective of improving patient safety and providing greater ...

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    Journal

    The importance of subjective and qualitative risk management for medical devices regulation

    2022-09-16T09:25:00Z

    In the early 2000s, risk management was thought to be able to offer the medical devices industry an exponential game-changing quality revolution. The developments brought by the Japanese quality philosophy, or total quality management, had seen many industries − such as aerospace and automobile production – make a paradigm shift ...

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    Journal

    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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    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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    Future Focus Topics

    2024 October Chemistry, manufacturing and controls November TOPRA Annual Symposium 2024 − Rotterdam December North America 2025 January Biologics February MedTech March Technology April Regional focus May Advanced therapies June Access to medicines July/August Green ...

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    Journal

    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.