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  • Regulatory NewsRegulatory News

    IMDRF proposes update on postmarketing device studies

    The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.   The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply t...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...
  • Regulatory NewsRegulatory News

    CHMP: Test all metformin for nitrosamines before release

    Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market, said a committee of the European Medicines Agency (EMA) following its scheduled September meeting.   “As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Comm...
  • Regulatory NewsRegulatory News

    EC lays out strategy for effective COVID vaccine rollout

    The European Commission (EC) has set out key steps for effective strategies member states should use to deploy vaccines against COVID-19 when they become available.   In the face of rising numbers of coronavirus cases even in areas of Europe that weathered an earlier surge and had seen numbers subside, the strategies advocated by the EC for member states include first building capacity to deliver vaccines, said EC in a communication to the European Parliament and Cou...
  • Feature ArticlesFeature Articles

    EU regulatory tools for RA professionals

    This article provides information on the key sources of information needed for understanding and keeping up-to-date with the European regulation of healthcare products, including medical devices and in vitro medical devices (IVDs), pharmaceuticals/medicinal products, and substances of human origin (blood, tissues, cells, and organs).   Introduction Regulatory professionals who need to understand the European regulation of healthcare products will find that the main s...
  • Regulatory NewsRegulatory News

    Study: Few new drugs have high therapeutic value

    A new study published in The BMJ  finds that only a third of new drugs approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the decade from 2007-2017 have high therapeutic value, according to appraisal by one of five independent organizations.   However, the analysis found that drugs approved through expedited programs – and especially EMA’s programs – were more likely to have high therapeutic value.   “Most of the incre...
  • Regulatory NewsRegulatory News

    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
  • Regulatory NewsRegulatory News

    EMA moves to IRIS for scientific advice questions

    The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary medicinal products.   The regulatory and scientific information management platform, known as IRIS , “aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through ...
  • Regulatory NewsRegulatory News

    MHRA issues post-transition orphan, Northern Ireland supply guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...
  • RoundupsRoundups

    Euro Roundup: UK, EU trade groups push Brexit negotiators to act to stop supply disruption

    Trade bodies representing the UK and European Union pharmaceutical industries have urged Brexit negotiators to act now to prevent disruption to the supply of medicines. The joint statement warns failing to form a mutual recognition agreement to soften a hard Brexit could cost both sides billions and delay the supply of medicines by up to six weeks.   The latest round of negotiations about the post-Brexit relationship between the UK and EU is due to end on Friday. If su...
  • Regulatory NewsRegulatory News

    EMA addresses use of registry-based studies

    The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.    After committee approval and a consultation period with the EU Regulatory Network, the guideline has been released for public consultation, with comments due before the end of 2020.   The guideline’s focus is on the use of patient registries for studie...
  • Feature ArticlesFeature Articles

    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...