RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    ACIP: First, vaccinate health care workers, nursing home residents

    In a 13-1 vote, the vaccines advisory committee of the Centers for Disease Control and Prevention (CDC) has voted to allocate the first rounds of COVID-19 vaccines to health care workers and residents of long-term care facilities.   “We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over finally,” said CDC’s Nancy Messonier, MD, director of the National Center for Immunization and Respiratory Disease...
  • 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...
  • RoundupsRoundups

    Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals

    The head of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined plans to get patients and the public more involved in product development. Chief executive Fujiwara Yasuhiro framed the initiative as part of an effort to increase the number of products that come to market in Japan before being authorized overseas.   Yasuhiro took over as chief executive of PMDA in April 2019. The following month, PMDA established the Patient Centricity Working Group to...
  • ReconRecon

    Recon: Hahn called to White House; Amgen, UCB and Takeda drugs enter new COVID trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US ready for 'immediate mass shipment' of COVID-19 vaccines: agency ( Reuters ) First US COVID-19 shots could be given 24-to-48 hours after FDA nod: health official ( Reuters ) FDA chief called to West Wing ( Axios ) ( CNN ) Regeneron, UPenn to use gene therapy tools to deliver a COVID-19 antibody drug ( BioPharmaDive ) White House to host Covid-19 vaccine su...
  • Feature ArticlesFeature Articles

    Comparison of pharmaceutical development drug regulatory pathways in the US and China

    The US has the largest pharmaceutical market in the world, as well as the highest expenditure in research and development (R&D). Right behind the US is China, in second place, as it steadily closes the gap, with increasing government investment in R&D and programs promoting the development of innovative medicines targeting the global market. To close that gap, there should be a strong R&D infrastructure, effective intellectual property protection, integration in global sta...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the  end of 2020  to the middle of  2021 .   To date, just two coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of th...
  • Regulatory NewsRegulatory News

    Moderna files COVID vaccine EUA; adcomm set for 17 December

    The pharmaceutical company Moderna has filed an emergency use authorization request with the US Food and Drug Administration (FDA) for the coronavirus vaccine the firm co-developed with the National Institutes of Health (NIH).  The company's vaccine against COVID-19 will be considered at a 17 December meeting of the FDA's Vaccines and Related Biological Products Advisory Committee. Announcing the meeting, FDA Commissioner Stephen Hahn, MD, said that the advisory committ...
  • Regulatory NewsRegulatory News

    ICMRA: Continue COVID vaccine trials "as long as is feasible"

    An international coalition of regulators has issued a statement in support of continuing clinical trials for vaccines against COVID-19 “for as long as is feasible,” but ideally for at least one year after vaccination.   The International Council of Medicines Regulatory Authorities (ICMRA) issued the statement in part to address a thorny ethical dilemma to be faced by vaccine sponsors and healthcare professionals when a vaccine is authorized: Should trial participants b...
  • Regulatory NewsRegulatory News

    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...