• Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
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    Project Orbis: Maximizing patient access to new medicines

    To ensure equitable access to new medicines for all patients, drug manufacturers aim to register new products in as many countries as possible. Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), is a pilot program that provides applicants with a framework for concurrent submission and review of oncology products among international partners to allow earlier registration in countries outside of the US. This article summarizes Genentech’s experience...
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    EU MDR survey: Time investment, costs, and personnel resources

    In 2020, a survey was conducted among medical device manufacturers to assess the true costs of the EU Medical Device Regulation for companies. The results show that the regulation requires considerable resources on the part of manufacturers in terms of time, costs, and personnel. Almost half the respondents said they believed the regulation would cost more than 5% of their annual turnover. However, most still relied on manual processes for their clinical data capture activ...
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    Tools for updating the IVDR template for demonstrating scientific validity

    In vitro diagnostic (IVD) testing has risen to meet the new EU regulations in the face of the significant pressures to achieve and perform adequately during the prevailing global adversity. That means existing templates must be structured to meet the new requirements of the In Vitro Diagnostic Regulation (IVDR) and demonstrate compliance with the general safety and performance requirements in Annex I of Regulation (EU) 2017/746. 1   The World Health Organization’s Glo...
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    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...
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    Navigating the maze of electronic submissions at EMA

    The European Medicines Agency (EMA) facilitates a range of different submissions and application processes using several submission systems for electronic procedures, which have clear advantages over paper-based submissions. At present, first-time applicants cannot proceed with a regulatory submission unless they have set up several accounts and assigned roles and registered their companies and their assets. However, there is no “one-stop-shop” place on the EMA website for...
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    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
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    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...
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    New US dietary guidelines expand nutrient considerations for life stages

    The US Department of Agriculture and Department of Health and Human Services have jointly published the Dietary Guidelines for Americans every 5 years since 1980 to provide science-based dietary recommendations to promote health and prevent chronic disease. The guidelines inform federal food and nutrition policy programs as well as local, state, and national health promotion and disease prevention initiatives. In addition, professionals in public health, healthcare, educat...
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    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
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    Soft skills training during a pandemic: Why it’s important, and how to do it

    In this article, the author discusses the importance of soft skills training during the COVID-19 pandemic in the context of their role in defining one’s employability and advancing both personal and team success in achieving goals. These training sessions will give employees an opportunity to connect virtually with their colleagues, improve morale, and provide skills that will increase productivity and create a more positive working environment. The article provides tools ...
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    Medical device software under the EU MDR

    The EU Medical Device Regulation (MDR) has been published with new medical device software (MDSW) requirements. Qualification guidance to determine if software is MDSW was combined with guidance for MDSW classification. However, the EU Medical Device Directive (MDD) guidance for clinical evaluation, which should have been replaced, is still in use. The change to the MDR has introduced new problems for clinical evaluation, so guidance has been introduced for equivalence, le...