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  • Regulatory NewsRegulatory News

    EMA reviewing application for Gilead’s remdesivir

    The European Medicines Agency (EMA) on Monday said it has received a conditional marketing authorization application for Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) that could receive an opinion in a matter of weeks.   “The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks depending on the robustness of the data submitted and whether further information is r...
  • Regulatory NewsRegulatory News

    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
  • Regulatory NewsRegulatory News

    European Commission consults on roadmap to pharmaceutical reforms

    The European Commission is looking to revamp parts of the regulatory framework for medicines in the EU to address shortages, access to medicines and innovation, according to a roadmap document released for consultation on Tuesday .   “There is a need to build a holistic, patient-centered, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access,” the Commission...
  • Regulatory NewsRegulatory News

    EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

    In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA) Executive Director Guido Rasi said the agency is trying to figure out how to be transparent with regard to clinical trial data for products it reviews to treat or prevent coronavirus disease (COVID-19).   After spending years implanting its policy for proactively publishing clinical data for products submitt...
  • Regulatory NewsRegulatory News

    CHMP backs eight new medicines, waiting on remdesivir application

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit an application for conditional marketing authorization for remdesivir to treat coronavirus disease (COVID-19).   The update on the status of remdesivir comes nearly a month after the committee began a rolling review of the dr...
  • Regulatory NewsRegulatory News

    EMA explains GMP and GDP flexibilities amid COVID-19

    The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).   (RELATED: EMA Q&A explains regulatory expectations for drugs during the...
  • RoundupsRoundups

    EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine

    Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment.   Concerns about the risks posed by administering hydroxychloroquine to COVID-19 patients have so far primarily focused on the link between the drug and cardiac arrhythmia. However, the history of use of hydroxychloroquine in the treatment of conditions including lupus and malaria shows the ...
  • Regulatory NewsRegulatory News

    EC eases rules for renewing notified body designations, explains process for EU-wide derogations

    The European Commission has issued new regulations easing the process for renewing notified body designations prior to the new date of application for the Medical Devices Regulations (MDR), 26 May 2021.   The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last y...
  • Regulatory NewsRegulatory News

    EMA extends virtual-only meeting policy through August

    The European Medicines Agency (EMA) on Tuesday announced it is extending its decision to hold all upcoming meetings virtually through August 2020 as a safety measure amid the ongoing coronavirus disease (COVID-19) pandemic.   EMA first made the shift to virtual-only meetings because of COVID-19 in March and extended the policy in April to continue through the end of May. Since mid-March, most EMA staff have worked remotely as well. (RELATED: Coronavirus: WHO declares...
  • Regulatory NewsRegulatory News

    Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi on Monday told a European Parliament committee that the agency could grant conditional marketing authorization to Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) in a matter of days.   “It might be that a conditional marketing authorization can be issued in the coming days, subject to the data that has been submitted,” Rasi said, adding that he does not believe the drug is ready to ...
  • Regulatory NewsRegulatory News

    EMA officials lay out need for ‘large, decision-relevant’ COVID-19 trials

    Top officials from the European Medicines Agency (EMA) say that international coordination is needed to ensure that clinical trials for treatments and vaccines for coronavirus disease (COVID-19) are conducted in a way that yields actionable and conclusive results.   “Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number...
  • Regulatory NewsRegulatory News

    Swedish notified body is 14th designated under MDR

    Sweden’s Intertek Medical Notified Body AB on Friday became the 14 th notified body designated under the EU Medical Devices Regulation (MDR).   The newly designated notified body is the fifth to be designated in 2020, following the designation of German notified body mdc medical device certification GmbH last month, and the first to be designated in Sweden. (RELATED: German notified body is 13th designated under MDR as MHRA plots delay guidance , Regulatory Focu...