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  • Regulatory NewsRegulatory News

    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...
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    CHMP backs eight medicines for approval, recommends ranitidine suspension

    At its meeting earlier this week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of eight medicines, including two versions of the first triple combination asthma inhaler and two new orphan medicines.   The committee also recommended the suspension of ranitidine medicines in the EU following a review of the drugs triggered by the detection of N-nitrosodimethylamine (NDMA) impurities. The recom...
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    EMA kicks off rolling review of Gilead’s remdesivir

    The European Medicines Agency (EMA) on Thursday said it has started a “rolling review” of Gilead’s investigational coronavirus disease (COVID-19) drug remdesivir after preliminary results from a US study found patients taking the drug recovered 31% faster than patients taking a placebo.   Preliminary results from the study, run by the National Institutes of Health (NIH), were announced Wednesday, the same day that less promising results from a Chinese study of the dr...
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    EMA explains new pharmacovigilance inspection follow-up procedures

    In a newly posted guideline that takes effect Friday, the European Medicines Agency (EMA) explains EU-wide follow-up procedures for pharmacovigilance inspections.   The 15-page document supersedes an earlier version for 2014 and includes new sections and a more detailed timeframe for post-inspection actions.   Following inspections, EMA says that lead inspectors should propose deadlines for responses to inspection findings, which should routinely be set at 30 worki...