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  • Regulatory NewsRegulatory News

    EMA Staff Losses Tick Up as Workload Increases

    As the interim arrangements to allow European Medicines Agency (EMA) staff to telework from London have now ended, the agency said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. “Due to these ongoing resource constraints, delivery of EMA’s work programme for Q4 2019 will be challenging for the Agency, particularly in view of the need to implement new legislation for veterinary medicines and medic...
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    EMA Begins Search for Next Executive Director

    As Guido Rasi wraps up his second five-year term as the executive director of the European Medicines Agency (EMA) on 15 November 2020, the search for a new head began officially on Tuesday. Based on the selection and eligibility criteria for the next executive director, according to a vacancy notice published in the Official Journal of the European Union, finding the right candidate will be a difficult process. For instance, prospective candidates will have to mana...
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    EMA Consults on Regulatory Science Strategy to 2025

    The European Medicines Agency (EMA) on Wednesday launched a six-month public consultation on its proposed strategy for regulatory science through 2025 following two recent multi-stakeholder workshops on the topic.   “The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said EMA Executive Director Guido Rasi, adding that the agency developed the plan with input from t...
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    EMA Offers Support for More Research on DIVI Biomarkers

    European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development. "Drug-induced vascular injury in nonclinical animal toxicology studies can cause considerable delays in the drug development pr...
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    European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Pilots Changes to Accelerate Drug Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year be...
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    European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (2 February 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Muddies Waters on Future UK-EMA Relationship Secretary of State for Exiting the EU David Davis has raised doubts about the likely relationship between the UK and the European Medicines Agency (EMA) after Brexit. Asked about the health secretary’s comments that Brexit would likely result in Britain leaving EMA, Davis said his colleague was “misreported an...
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    EMA's Rasi on Brexit: Climate of Uncertainty Straining Worker Motivation

    At a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday, the European Medicines Agency’s Executive Director Guido Rasi said the agency needs additional measures to support its staff as the uncertainty over Brexit is taking its toll on staffers. “We need additional measures to support the staff,” Rasi told the committee, noting that there were six resignations at the drug regulator in the first month after Britain ...
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    EMA's 2015 Annual Report: Interest in Scientific Advice Increasing

    The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year. According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled , leaving the agency without a head until November of the following year when Rasi was re-appointed . Despite the disruption to EMA's le...
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    EMA Looks to Accelerate New Therapies Targeting Unmet Needs

    The European Medicines Agency (EMA) on Monday launched its new PRIME (PRIority MEdicines) scheme which aims to streamline the development of promising new therapies that meet unmet medical needs. Like the breakthrough therapy program in the US, the new EMA program aims to accelerate the development of new drugs to treat rare cancers, Alzheimer's and other neurodegenerative diseases, AIDS and diabetes, among others. "I think we still see too many patients in desperate n...
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    EMA Executive Director: Agency Ready for Challenges Ahead

    The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term. In his first press briefing since being reinstated as Executive Director of EMA in November, Rasi says he sees three major factors that will set the tone during his term. First, Rasi says "our understanding of the human body and the underlying science [of medicine] has vastly grown" in recent years. To meet this chal...
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    Rasi Returns to Head EMA for Five-Year Term

    The European Medicines Agency's (EMA) former leader has officially returned to head the agency today, after being forced to step down from his previous appointment last November. With today's announcement, Professor Guido Rasi begins a new five-year term as EMA's executive director. Background In November 2014, the EU Civil Service Tribunal annulled Rasi's appointment after Emil Hristov, former head of the Bulgarian Drug Agency, challenged the appointment process use...
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    A Second Chance? EMA Board Nominates Guido Rasi to Lead Again

    The European Medicines Agency’s (EMA’s) Management Board on Thursday nominated Professor Guido Rasi as the executive director of the agency, a little less than a year after he was forced to step down from the position. Rasi has been invited to give a statement to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on 13 October 2015, and the appointment of the new executive director will be made after this session. The EMA told ...