• AdobeStock_294408431

    The health economics profile of new pharmaceuticals


    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 ...

  • AdobeStock_449245189 (1)

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


    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 ...

  • AdobeStock_74929002

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


    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 ...

  • AdobeStock_168373953

    Navigating the MDR’s heightened surveillance and performance requirements


    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 ...

  • AdobeStock_505106152 (3)
  • AdobeStock_498683522

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


    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 ...

  • Reg-Ops-MAIN

    The changing role of regulatory operations


    The regulatory profession has always attracted diverse individuals with a wide range of professional experiences. Top talent has migrated from preclinical labs, clinical operations, quality, and a range of functions to pursue a career in regulatory operations. The role of the regulatory operations professional has and continues to evolve as the requirements for the position have changed drastically. These professionals have witnessed a substantial change in the responsibilities associated with their role. These changes are directly related to those in global submission requirements and associated standards, emerging technologies, and shift ing resourcing models, among other factors.

  • Regul-Process-HERO
  • Harmonising-HERO

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


    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.

  • Data-Remed-HERO (002)

    How data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals


     Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.

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

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


    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.

  • Older-People-HERO

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


    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.

  • AdobeStock_507759233

    Jul/Aug 2022 CPD supplement - FDA meetings: how to hold a successful meeting across the drug development lifecycle


    To support its mission of protecting and advancing public health, the US FDA has established formal mechanisms to engage with sponsors and applicants. Meetings with the Agency are a critical component of the review and approval process for prescription drugs, biologics and medical devices. Meaningful, timely and formal FDA advice helps to de-risk and accelerate a product’s development, review and approval process. 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

  • 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_264649866

    Translating digitalisation trends into tangible solutions


    Pharmaceutical companies are seeking to take advantage of digital innovations to become data-driven organisations, but rstly, they must overcome various data challenges to move from concept to execution. Timm Pauli, Head of R&D Informatics at PharmaLex, and Dr. Torsten Osthus, Advisory Consultant to PharmaLex and Managing Director of Osthus Group, (whose service division, Osthus Services, recently merged with PharmaLex), explore the path to successful R&D digitalisation.

  • 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_393791829

    Data governance as a strategic imperative for regulatory compliance


    Data governance is a multi-faceted arrangement that relies on data quality, data integrity, data and document management, security and safe storage. It is critically important to companies and regulators as they evaluate product quality, the manufacturing process and the reliability of study data from non-clinical and clinical research. The integrity ...

  • AdobeStock_297198041

    Digital and data-driven: a regulatory insight into 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

    Feb 2019 CPD Supplement-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.