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  • 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 ...
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    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...
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    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...
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    EMA waives certain GMP inspection fees during COVID-19

    The European Medicines Agency (EMA) this week announced it is waiving fees for on-site good manufacturing practice (GMP) inspections of drugmakers and blood establishments that have undergone remote inspections during the coronavirus disease (COVID-19) pandemic under certain circumstances.   Specifically, EMA says it will fully waive fees for sites that undergo remote inspections where GMP compliance cannot be confirmed and the inspection must be rescheduled “due to th...
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    EMA official says COVID-19 vaccine could be approved in a year

    A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency’s top official overseeing anti-infectives and vaccines, said Thursday.   Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September .   “I have to stress that...
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    EC sets timeline for rolling out Eudamed modules

    The European Commission will begin making some Eudamed modules available next year, including the actor registration module originally anticipated this month, according to an email to members of the Eudamed working groups.   The message was circulated after the one-year delay of the Medical Devices Regulation (MDR) was adopted by the European Council in late April and follows the Commission’s decision to delay the application of Eudamed by two years to May 2022. (REL...
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    MDCG offers guidance on safety reporting for device studies under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday released a new guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the Medical Devices Regulation (MDR).   The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory F...
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    Refine gene therapy follow-up guidance, expert says

    It’s time for regulatory agencies, academics and pharmaceutical companies to convene to refine guidance for long-term follow-up of patients receiving gene therapy. That was the message Anne-Virginie Eggimann, senior vice president for regulatory science at bluebird bio, Inc., brought to a policy session at the annual meeting of the American Society of Gene & Cell Therapy .   To date, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) hav...
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    Remdesivir: EMA recommends wider compassionate use

    The European Medicines Agency (EMA) on Monday recommended expanding compassionate use programs for Gilead Sciences’ investigational drug remdesivir to treat coronavirus disease (COVID-19) patients who are not on mechanical ventilation and to allow for a shorter treatment duration based on the results of two recent clinical studies.   In early April, EMA released its initial recommendations for providing remdesivir through compassionate use programs for patients who are...
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    EMA preparing big data Q&A guidance

    The European Medicines Agency (EMA) says it is preparing a question and answer guidance on the application of EU data protection rules to the secondary use of health data in medicines development, evaluation and supervision.   EMA explains that secondary use of data describes “the use of data for a different purpose than the one for which it was originally collected,” and applies to various real-world data sources such as electronic health records, health insurance cla...
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    CE certificates up nearly 50% in 2019 in anticipation of MDR

    In its annual sector survey, the European notified body group Team-NB found a nearly 50% uptick in the number of new CE certificates issued in 2019 as medical device makers rushed to obtain the certificates before the application of the EU Medical Device Regulation (MDR).   While the MDR is now officially delayed by one year, companies planning for the transition in 2019 were braced for the regulation to take effect later this month. (RELATED: MDR delay official as i...
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    EMA details rapid procedures for COVID-19 products

    The European Medicines Agency (EMA) on Monday laid out its tools for expediting the development and approval of medicinal products for coronavirus disease (COVID-19), including faster scientific advice, rolling reviews and accelerated assessments.   “Supporting the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency,” said EMA Dir...