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    RAPS publishes updated, ninth edition of essential European regulatory affairs reference

    RAPS has just published the updated, ninth edition of Fundamentals of EU Regulatory Affairs . The book remains the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices and biologics for the European market. As the regulation of healthcare products in the EU continues to undergo significant transformation, RAPS’ Fundamentals of EU Regulatory Affairs, Ninth Edition , has been updated to cover topics including the latest informa...
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    EU agencies clarify pharmacovigilance expectations amid COVID-19

    In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) expand on their expectations for pharmacovigilance.   The updated document features three new questions related to pharmacovigilance, covering topics from corrective and preventive actions management to pharmacovigila...
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    EMA revises methodological guidance for trials impacted by COVID-19

    Following a four-week public consultation, the European Medicines Agency (EMA) on Monday revised its guidance on methodological considerations for ongoing clinical trials amid the coronavirus disease (COVID-19) pandemic.   The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing th...
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    EMA recommends eight new medicines, refuses one

    A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.   The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about dur...
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    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    EMA recommends remdesivir to treat COVID-19, authorization expected next week

    Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.   EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug t...
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    European Commission proposes relaxing GMO regs for COVID-19 vaccines

    A proposal to adjust European Union regulation of genetically modified organisms (GMOs) would relax requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.   “The policy objective of this proposed regulation is to ensure that clinical trials with medicinal products for human use...
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    Fourth notified body designated under IVDR

    Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).   TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.   The newly designated notified body will be a welcome addition for industry, as the number of notified bodies des...
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    Regulators discuss accelerated approvals, Project Orbis at DIA

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the DIA Global Annual Meeting.   All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated ap...
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    EMA management board backs rolling review fees, COVID-19 transparency measures

    After its June meeting on Thursday, the European Medicines Agency’s (EMA) management board said it has approved a new fee for rolling reviews and that the agency will be providing more details about its approach to publishing clinical data for vaccines and drugs for coronavirus disease (COVID-19).   The new rolling review fee “would be deducted from the fee that would become due with the submission of an actual marketing authorisation application.” The specific fee a...
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    MDCG issues guidance on transitioning devices with ancillary substances to MDR

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance explaining the process for transitioning CE certificates for devices containing an ancillary substance that could be considered a medicinal product or those manufactured using animal tissues under the Medical Devices Regulation (MDR).   The document also explains some of the differences in requirements and consultations from previous legislation.   Ancillary substances ...
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    EMA issues guidance on remote GCP inspections

    The European Medicines Agency (EMA) on Wednesday posted new guidance explaining how remote good clinical practice (GCP) inspections should be conducted amid the coronavirus disease (COVID-19) pandemic.   EMA says that GCP inspections are “indispensable” to its assessment of marketing authorization applications, especially during a public health crisis. European authorities have previously provided guidance on good manufacturing practice (GMP) certificates allowing for ...