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    Regulatory pathways for innovative medicinal products for Switzerland

    Switzerland is not part of the EU or the European Economic Area (EEA), therefore, a national marketing authorization application (MAA) for Switzerland must be filed and approved before a medicinal product can be placed on the Swiss market. Besides the standard MAA procedure, there are expedited, simplified, and work-sharing procedures that can be selected, depending on the product characteristics. This article provides an overview of relevant Swiss marketing authorization ...
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    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
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    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
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    Euro Roundup: UK’s NICE launches five-year strategy

    The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.   “The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.   The strategy is built...
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    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
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    EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers   Ireland’s Health Products Regulatory Authority (HPRA) has reported an almost four-fold increase in its annual number of marketing authorization holder (MAH) transfers. The jump covers the run up to the date on which the United Kingdom was originally due to leave the European Union.   In...
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    EU Regulatory Roundup: CHMP Questions Delay Novartis Gene Therapy Approval Timeline

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   CHMP Questions Delay Novartis Gene Therapy Approval Timeline   Tougher than expected regulatory scrutiny has delayed Novartis’ efforts to bring its spinal muscular atrophy gene therapy Zolgensma to patients in Europe. Novartis had hoped to win approval by the end of the year, but now expects the Committee for Medicinal Products for Human Use (CHMP) to deliver its op...
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    EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit   The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the European Union in the event of a no-deal Brexit.   If the UK leaves without a deal the E...
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    EU Regulatory Roundup: MHRA Expands Guidance on Assistive Technology to Help Device Industry

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Expands Guidance on Assistive Technology to Help Device Industry   The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidance on assistive technologies, products that support people with disabilities, restricted mobility or other impairments.   MHRA published guidance on the definition and safe use of assistive te...
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    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...
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    Swissmedic Begins Working With EudraGMDP Database

    As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database. The European Medicines Agency (EMA) noted on Thursday that the Swissmedic entries apply to all new or renewed manufacturing authorizations and the related GMP-certificates issued using new template...
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    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...