• Regulatory NewsRegulatory News

    Regulators release 10 principles for good machine learning practice

    Regulators from the US, Canada, and the United Kingdom unveiled 10 principles to guide the development of good machine learning practice for medical devices.   The principles are meant to be used to drive the adoption of good practices that have been proven in other sectors, to help tailor those practices so that they are applicable to medical technology, and to create new practices specific to the health care sector. The document, which was issued by the US Food and...
  • RoundupsRoundups

    Euro Roundup: UK sets up group to involve patients in ILAP pathway

    UK sets up group to involve patients in Innovative Licensing and Access Pathway   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has formed a patient group to support its Innovative Licensing and Access Pathway (ILAP). MHRA set up the group to ensure that “patient views are an integral part of the ILAP ambition.”   UK officials shared details of ILAP late last year, describing how the pathway will accelerate time to market by enabling drug de...
  • ReconRecon

    Recon: NYT says Abbott destroyed COVID tests when sales dwindled; Woodcock out of running for FDA commissioner?

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Maker of Popular Covid Test Told Factory to Destroy Inventory ( NYT ) Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee ( Bloomberg ) Child Covid-19 hospitalizations soar, filling pediatric wings, data show ( NBC ) White House: More than one million vaccine doses administered in past 24 hours ( The Hill ) Three senators announce positive COVID-19...
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    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...
  • Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
  • Regulatory NewsRegulatory News

    MHRA announces streamlined clinical trial review process

    In the wake of the systemic changes flowing from the UK’s exit from the EU, the country’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline review of clinical trials for medicinal products.   Beginning in January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will receive a combined review from MHRA and the UK Research Ethics Services, with collaboration from the UK’s Health Research Authority (HRA). The process is...
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    Euro Roundup: EDQM says remote inspections could be third pillar for GMP oversight

    Real-time remote inspections piloted during the COVID-19 pandemic could serve as a third pillar for the supervision of active pharmaceutical ingredient (API) manufacturers, the European Directorate for the Quality of Medicines (EDQM) said.   EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections EDQM performs each year happen...
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    Euro Roundup: EU launches survey for COVID-19 drug developers

    The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.   (RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end , Regulatory Focus 6 May 2021)   In the survey, the EU asks for information about the COVID-19 therapies companies are developing, includi...
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    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
  • Feature ArticlesFeature Articles

    The UK regulatory landscape post Brexit

    The withdrawal of the UK from the European Union was fully effective on 1 January 2021, with the Medicines and Healthcare products Regulatory Agency (MHRA) becoming the UK’s standalone medicines and medical devices regulator. Medicine developers need to be aware of the rules they now have to follow for getting their products approved for the UK market. MHRA has published extensive guidance, and this article aims to highlight the most relevant initiatives.   Introducti...
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    Euro Roundup: MHRA seeks feedback on patient engagement strategy

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on how it engages with patients and involves them in its activities. MHRA is initiating the review in the wake of criticism of how it responded to patient concerns about the safety of products such as surgical mesh.   In the consultation document, MHRA describes five strategic, patient-focused objectives and shares details on how it intends to achieve the goals. The first goal is to “...
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    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...