• Regulatory NewsRegulatory News

    EMA wants participants to serve on clinical trial multistakeholder forum

    The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to participate in a new multistakeholder platform (MSP) or forum to share and implement ideas for improving clinical trials in the EU.   The call for participation is being launched under last year’s EC-HMA-EMA initiative Accelerating Clinical Tri...
  • RF Quarterly

    Change control in the artificial intelligence era

    Artificial intelligence as medical devices (AIaMDs) have the power to learn from real-world performance and over time and may provide a different output compared with that initially cleared for a given set of inputs. However, regulatory frameworks have remained relatively unchanged and are largely focused on approaches around traditional hardware-based medical devices. In this article, the authors explain the US Food and Drug Administration’s (FDA’s) current thinking on en...
  • Regulatory NewsRegulatory News

    Prompted by recent recalls, regulators scramble to address novel nitrosamines

    Updated 3 November 2022* The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.   The situation raises new questions about how to set daily acceptable intake limits for pharmaceutical products when toxicological data on these impurities is scarce.   These novel nitrosamines, ...
  • Regulatory NewsRegulatory News

    CHMP recommends 12 new medicines, including first RSV treatment for infants

    The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.   The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was s...
  • Regulatory NewsRegulatory News

    Convergence: EU official says no delay to CTIS implementation, despite industry concerns

    PHOENIX, AZ – Country-specific requirements that diverge from the Clinical Trials Regulation (CTR) and the lack of a forum for resolving issues with the Clinical Trial Information System (CTIS) portal were among the key issues industry representatives brought to a session at RAPS Convergence 2022.   Another problem is that the portal does not flag or send information to sponsors when new information is received, so sponsors must check frequently for updates.   In t...
  • Feature ArticlesFeature Articles

    ARTICLE OF THE YEAR: The linguistic review process in the centralized procedure in the EU

    In the EU and European Economic Area (EEA), certain products receive marketing authorization through the centralized procedure (CP). Following this, a number of documents, such as the product information (PI), require translation into all 24 EU and EEA official languages. The translations provided by the marketing authorisation holder (MAH) are approved by the corresponding EU member states. This review and approval process of the 24 languages is known as the linguistic re...
  • Regulatory NewsRegulatory News

    EMA reports steady rise in clinical trial applications registered in CTIS portal

    Nearly 195 clinical trial applications (CTAs) have been submitted to the European Medicine Agency’s (EMA) Clinical Trial Information System (CTIS) portal through July, marking a substantial increase from a month earlier, according to a 23 August report from the agency.   However, during the same period, most applications (224) were still being registered in the older EudraCT database. (RELATED: EMA reports slow uptick in clinical trial applications submitted via CT...
  • Regulatory NewsRegulatory News

    EMA reports slow uptick in clinical trial applications submitted via CTIS portal

    The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.   Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to a...
  • Regulatory NewsRegulatory News

    EMA to address nitrosamine impurities in upcoming revision of active substances guidance

    The European Medicines Agency (EMA) will be updating its guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients (APIs), the agency announced in a new concept paper .   The revised guideline is meant to address risk factors for formation of nitrosamines in medicinal products and strategies for preventing their formation and presence.   EMA and other regulators have ...
  • Regulatory NewsRegulatory News

    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
  • RF Quarterly

    China’s NMPA: The evolution of medical device regulation

    This article describes the main changes of China's drug and device regulatory system in the past 70 years, with the focus on medical devices rather than drugs. The article highlights the latest changes in the regulation of medical devices and examines international cooperation in the field of medica devices and the regulatory framework for the medical device product life-cycle in China. It also includes the latest updates for medical device regulation in 2022 and beyond. ...
  • Regulatory NewsRegulatory News

    Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments

    An EU official advised manufacturers of advanced therapy medicinal products (ATMPs) to consult the European Medicines Agency’s (EMA) recently issued “toolbox” guidance to avoid having products rejected from being eligible for accelerated review under the PRIME program for quality-related deficiencies.   Barbara Bonamassa, a reviewer with the Italian Medicines Agency (AIFA), offered an update on some of the EU’s ongoing activities to expedite the development of ATMP the...