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    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
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    CHMP’s February recommendations: Evrysdi, Jemperli, and a generic for prostate cancer

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended six new medicines for approval when it met in February, including two biosimilars and one generic medicine.   The committee recommended marketing authorization for Roche’s Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA). It is the first oral treatment for this condition and was reviewed under the EMA’s accelerated assessment pr...
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    EU MDR survey: Time investment, costs, and personnel resources

    In 2020, a survey was conducted among medical device manufacturers to assess the true costs of the EU Medical Device Regulation for companies. The results show that the regulation requires considerable resources on the part of manufacturers in terms of time, costs, and personnel. Almost half the respondents said they believed the regulation would cost more than 5% of their annual turnover. However, most still relied on manual processes for their clinical data capture activ...
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    EMA releases guidance for COVID variant vaccine development

    The European Medicines Agency (EMA) has published a reflection paper laying out what data are needed to support approval of vaccines that protect against variants of SARS-CoV-2, the virus that causes COVID-19.   “[I]t is an urgent public health priority to define an expedited regulatory process for the adaptation of vaccines to protect against current or future variants,” wrote the agency in announcing the new guidance. The document comes less than 2 weeks after a vari...
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    Tools for updating the IVDR template for demonstrating scientific validity

    In vitro diagnostic (IVD) testing has risen to meet the new EU regulations in the face of the significant pressures to achieve and perform adequately during the prevailing global adversity. That means existing templates must be structured to meet the new requirements of the In Vitro Diagnostic Regulation (IVDR) and demonstrate compliance with the general safety and performance requirements in Annex I of Regulation (EU) 2017/746. 1   The World Health Organization’s Glo...
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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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    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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    European Commission explains management of legacy devices in Eudamed

    The European Commission this week posted a new document explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database.   After being delayed in 2019, Eudamed, a critical component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched with the first of its six modules operational in December 2020. The remaining five modules are expected to roll out by the database’s May 2022 date of a...
  • 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...