• RoundupsRoundups

    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
  • Regulatory NewsRegulatory News

    Industry and patient groups call for IVDR delay

    In the wake of the 26 May EU implementation of the new medical device Regulation (MDR), a trade group, a patient association and a data analytics firm have jointly called for a delay in implementation of the parallel In Vitro Diagnostics Regulation (IVDR), now slated for 26 May 2022. Without a course correction, the organizations cite the potential for serious disruptions in patient care, especially in targeted therapies for cancer patients.   With just a year to go ...
  • Ophthalmic manufacturers get UDI guidance from MDCG

    In a new position paper, the EU’s Medical Device Coordination Group (MDCG) has provided detailed information about device identifiers for eyeglass and lens manufacturers.   The position paper is meant to clarify how manufacturers of spectacle lenses and “ready readers,” or non-prescription reading glasses, should address unique device identification (UDI) requirements under the newly applied Medical Devices Regulation (MDR).   Articles 10(7) and 27(3) of the MDR ob...
  • Regulatory NewsRegulatory News

    MDR's Day One: Experts weigh in

    Editor’s note: Today, MDR comes into effect. We took the opportunity to check in with medical device regulatory experts now that the day is at hand. This “ News in Focus ” article is the first in an occasional series where we will provide expert perspective or opinion on regulatory news. Look to Regulatory Focus for more insights on other topics in the coming weeks.   In the EU, the day has come. On Wednesday, the European Commission applied the updated suite of re...
  • Regulatory NewsRegulatory News

    EMA boosts mRNA vaccine capacity, refines AstraZeneca risk-benefit

      The European Medicines Agency (EMA) is working to secure additional doses of the COVID-19 vaccine developed by Pfizer and BioNTech with an aim to deliver 1.8 billion doses to Europe by the end of 2023.   After touring the Pfizer plant in Puurs, Belgium, European Commissioner Ursula von der Leyen issued a joint statement with Belgium’s prime minister and BioNTech’s chief medical officer. “I am now confident that we will have sufficient doses to vaccinate 70% of th...
  • Regulatory NewsRegulatory News

    EMA, Health Canada publish Moderna data package

    Making good on an earlier commitment to transparency in regulatory decision-making during the COVID-19 pandemic, the European Medicines Agency (EMA), in collaboration with Health Canada, has published the full clinical data package upon which the regulators based their approvals of the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.   The Tuesday announcement of the availability of the data package “highlights the shared commitme...
  • Regulatory NewsRegulatory News

    Industry calls for IP protection, innovation support in EC pharmaceutical roadmap

    The European Commission (EC) has posted feedback it received on a new roadmap for a pharmaceutical strategy aimed at increasing timely patient access to affordable medicines. The feedback period began 16 June; a period of public consultation remains open until 15 September, with commission adoption planned for the 4 th quarter of 2020. Organizations leaving feedback generally welcomed the development of the roadmap, but many pharmaceutical manufacturers and trade assoc...
  • Regulatory NewsRegulatory News

    EC details device assessment capacity amid COVID-19

    European notified bodies reported on their ability to conduct conformity assessment quickly for COVID-19-related medical devices and in vitro diagnostic medical devices, in response to a survey conducted by the European Commission (EC).   The survey sought to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the European Union (EU) and for which notified bodies need to be involv...
  • Regulatory NewsRegulatory News

    EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

    The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020. The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the...
  • Regulatory NewsRegulatory News

    EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer. The review of using primates for biomedical research comes as...
  • Regulatory NewsRegulatory News

    Regulators, Industry Weigh in on Proposed EU Orphan Regulation Changes

    As the number of orphan drug approvals continues to rise in the EU, the European Commission is now considering feedback from European governments, regulators and industry on how changes to five aspects of the Orphan Regulation may further incentivize the development of drugs for rare diseases. To date, the commission has authorized 117 orphan medicines, 82% of which consist of new active substances, according to a new report .  And while the number of products authorize...
  • Regulatory NewsRegulatory News

    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...