All European Union articles

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    Industry news

    EMA platform to monitor use of antimicrobials


    All EU member states are required to submit data on sales and use of antimicrobials in animals to the EMA’s new platform.

  • EU-IVDR-3-to-2

    A year of clinical trials under IVDR:
    a sponsor’s perspective

    The new EU in vitro diagnostic medical devices regulation (IVDR) extends to medical use of in vitro diagnostics (IVDs) in clinical trials, in addition to marketed IVDs. Although compliance to some aspects has been required since the Date of Application on 26 May 2022, there has been ...

  • Hearing aid

    Regulatory challenges and opportunities facing hearing aid manufacturers in Europe

    In a world where many people are living longer but not all are living well and age-related hearing loss affects approximately 20% of the European population aged 65 or older – hearing aids address a medical need which for the most part remains unmet. With increasing evidence ...

  • Cristian Silviu Bușoi MEP

    European Parliament gives first stage approval for revised EMA fees


    MEPs in Strasbourg follow the parliament’s health committee’s approval of report to revise how EMA charges.

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    Procedure withdrawals within Europe: past trends, impact and communication recommendations


    When an application for a new veterinary medicinal product (VMP) is submitted through a MR/DCP, the Applicant has the option to prematurely withdraw their application in the reference member state (RMS) or in one or several of the concerned member states (CMS). This would result in a total or partial withdrawal of the procedure. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) sent a questionnaire to all national competent authorities…

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    The EU restriction proposal for intentionally-added microplastics: A focus on solid dosage form medicinal products and food supplements


    Among the European initiatives to address the growing concern of plastics in the environment, the European chemicals agency (ECHA) has prepared a restriction proposal for intentionally-added microplastics amid concerns about plastics in the environment. An introduction to the proposal and its impact on consumer products.

  • Brexit supply chain

    Brexit − Regulatory and supply chain considerations


    The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...

  • post brexit

    Pharmacovigilance regulations post-Brexit


    The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...

  • eu
    Meeting Report

    IVD3: EU Implementation: Current State


    The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…

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    EU PIP breast implant withdrawal


    The Poly Implant Prothèse (PIP) silicone breast implant failures had a socioeconomic impact at an international level, affecting nearly 400,000 patients in 55 different countries,[1] and resulted in major EU regulatory updates. PIP was a French company founded in 1991 and it produced approximately two million sets of silicone breast ...

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    Fundamentals of the European devices regulatory framework


    In the EU, the development of medical devices is supported by the European Commission Directive (93/42/EEC Medical Devices Directive). To this, the EU has a unique system in dealing with medical devices, iconised as the CE Marking, which provides the right for the products to be commercialised in the EU. This continuing professional development supplement presents the unique system of medical devices that is currently applied in the EU. Additionally, the new regulation of medical devices (EU 2017/745 Medical Device Regulation) is also covered.