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    EMA plots earlier engagement with patient groups

    The European Medicines Agency’s (EMA) on Friday announced it will pilot an early engagement program to bring patient and consumer groups to the table with its human medicines committee earlier in the evaluation process.   In its proposal for the pilot, EMA says there are “missed opportunities” for its Committee for Medicinal Products for Human Use (CHMP) to incorporate patient perspectives into its reviews, as patient input is typically sought late in the process and o...
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    EMA: Lentiviral thalassemia treatment on hold pending cancer investigation

    The European Medicines Agency (EMA) was notified by a gene therapy firm that the company has suspended marketing of its beta thalassemia treatment Zynteglo (betibeglogene autotemcel, bluebird bio) as a precautionary measure.   In a press release , the agency related that bluebird bio’s actions came after a recipient of the related bb1111 gene therapy for sickle cell disease developed acute myeloid leukemia (AML). Another bb1111 recipient has also developed myelodyspla...
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    EU plan to tackle COVID variants features flu vaccine-like pathway

    The European Union’s plan to take on new and emerging COVID-19 variants came into focus Wednesday with the European Commission’s announcement of a new incubator tasked with scanning for and assessing variants, speeding regulatory approvals and boosting EU production of vaccines.   The incubator is said to lay the groundwork for the recently proposed European Health Emergency Preparedness and Response Authority (HERA), which the Commission has billed as a “central eleme...
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    Janssen's COVID vaccine application submitted to EMA

    The European Medicines Agency (EMA) announced Tuesday that Janssen, a division of Johnson & Johnson, has submitted an application for conditional marketing authorization for its one-dose vaccine against COVID-19.   The submission package now goes before EMA’s human medicines committee (CHMP) for an accelerated assessment. “The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are suff...
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    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
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    CureVac's COVID vaccine enters EMA's rolling review

    The European Medicines Agency (EMA) has begun a rolling review of another vaccine against COVID-19, the agency announced Friday.   EMA’s human medicines committee (CHMP) will review available data on CureVac’s messenger RNA (mRNA) vaccine CVnCoV. The vaccine is currently being tested in a Phase 2b/3 clinical trial of about 36,000 participants in Germany, as well as in a German Phase 3 trial involving healthcare workers.  (RELATED: COVID-19 vaccine tracker , Regul...
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    Navigating the maze of electronic submissions at EMA

    The European Medicines Agency (EMA) facilitates a range of different submissions and application processes using several submission systems for electronic procedures, which have clear advantages over paper-based submissions. At present, first-time applicants cannot proceed with a regulatory submission unless they have set up several accounts and assigned roles and registered their companies and their assets. However, there is no “one-stop-shop” place on the EMA website for...
  • EMA plans guidance on adapting vaccines for COVID variants

    The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.   The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants , Regulatory Focus 5...
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    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
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    EMA, MHRA update on COVID vaccine pharmacovigilance

    Regulators in Europe are beginning to give safety readouts from global experiences with vaccines against COVID-19, while the United Kingdom has issued a report delineating its multi-pronged safety surveillance approach.   The European Medicines Agency’s safety committee met at the end of January to review data from clinical use of the COVID-19 messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health.   Following a 28 January mee...
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    EMA pilot brings outside regulators into committee work

    A new collaborative initiative is bringing the perspective of non-European Union regulators into the evaluation process for vaccines and therapeutics to combat COVID-19.   The pilot program, dubbed OPEN, debuted in December 2020. On Thursday, the European Medicines Agency (EMA) published a series of questions and answers (Q and A) fleshing out how the collaboration is working.   “The pilot will foster better understanding of regulatory outcomes, while retaining sci...
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    GVP: EMA consults on revised risk minimization module

    The European Medicines Agency (EMA) on Wednesday released draft versions of the third revision to its good pharmacovigilance practice (GVP) module XVI guideline on risk minimization measures and its second addendum to the guideline on methods for evaluating the effectiveness of risk minimization measures for public consultation.   The deadline to comment on the documents is 28 April 2021 and EMA says it expects the revised guideline and new addendum to come into effect...