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  • Regulatory NewsRegulatory News

    Pfizer, Moderna apply for EMA authorization; Janssen's candidate begins rolling review

    Two vaccines against COVID-19 are under consideration for conditional marketing authorization by the European Medicines Agency (EMA), and a fourth vaccine candidate has entered the regulator’s rolling review process.   The European regulator could deliver an opinion on applications “within weeks” for the two messenger RNA (mRNA) vaccines developed by collaborations between Pfizer and BioNTech and between Moderna and the National Institutes of Health .   “Such a ...
  • Regulatory NewsRegulatory News

    EC names fifth notified body for IVDR

    The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR , Regulatory Focus 26 September 2019)   Implementation of MDR has been delayed by a year to May 2021 because of concerns abou...
  • Regulatory NewsRegulatory News

    Eudamed launched with actor registration module live

    The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.   “Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medi...
  • Feature ArticlesFeature Articles

    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
  • Regulatory NewsRegulatory News

    EC’s new pharmaceutical strategy highlights support for innovation, R&D

    The European Commission (EC) has adopted its pharmaceutical strategy for Europe. The announcement follows a period of consultation earlier this year and meets the EC’s goal of finalizing the strategy by year’s end.   The strategy is not focused on the COVID-19 pandemic, but strategies and considerations included in the document were informed by the impact of the novel coronavirus in Europe and globally.  The primary objectives of the strategy fall into four categories. ...
  • Regulatory NewsRegulatory News

    EMA revises remote pharmacovigilance inspections guide

    The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic.   The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis.   In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expande...
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    COVID rapid diagnostic options expand with at-home LAMP test

    US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the first COVID-19 diagnostic test that can be used to provide rapid results at-home.     The newly authorized Lucira COVID-19 All-in-One test kit is a molecular test that uses real-time loop-mediated amplification (LAMP) technology to detect the presence of SARS-CoV-2, the virus that causes COVID-19. The test enters the market as the pandemic surges worldwide and governments are re-...
  • Feature ArticlesFeature Articles

    Getting ready for the EU IVDR transition

    This article discusses a manufacturer’s challenges and solutions to preparing currently marketed in vitro diagnostic (IVD) devices for new requirements under the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746.   Introduction It is daunting, in the best times, to work together to develop and manufacture IVD tests and instrumentation and coordinate their readiness for regulatory review. To get functional area heads in a global company to review and summarize ...
  • Regulatory NewsRegulatory News

    EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

    In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.   The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.   EMA’s human medicines committee (CHMP) had positive recommendat...
  • Regulatory NewsRegulatory News

    MDCG releases long-awaited IVD classification guidance

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR).   The nearly 50-page guidance is intended to explain how IVDs should be classified to manufacturers, notified bodies and healthcare providers before they are placed on the EU market and is seen as critical to industry’s ability to accurately classify ...
  • Regulatory NewsRegulatory News

    Rasi signs off as EMA chief, Cooke to take the reins amid pandemic

    Guido Rasi, the European Medicines Agency’s (EMA) long-serving executive director, ended his second five-year term on Friday, handing the reins to Emer Cooke, who is returning to the agency after a stint at the World Health Organization (WHO).   Cooke, who will be the first woman to lead the agency in its 25-year history after being nominated for the role in June, will begin her tenure at the height of the COVID-19 pandemic where her role as the EU’s top regulator will...
  • Regulatory NewsRegulatory News

    EMA rolls out COVID vaccine monitoring plan

    As it continues its rolling review of COVID-19 vaccine candidates, the European Medicines Agency (EMA) has laid out its COVID-19 vaccine safety monitoring plan. In addition to the agency’s usual vaccine monitoring requirements, the monitoring plan imposes new monthly reporting obligations on companies marketing vaccines.   A new guidance is also available to assist firms in the specifics of developing COVID-19-specific vaccine risk management plans (RMPs).   Togeth...