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  • RoundupsRoundups

    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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    RoundupsRoundups

    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...
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    EU Regulatory Roundup: Industry Finds Fault With UK Vision for Drug Regulation After Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Industry Finds Fault With UK Vision for Drug Regulation After Brexit   British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, ...
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    EU Regulatory Roundup: UK High Court Rejects Interpretation of EMA Powers

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK High Court Rejects Interpretation of EMA Powers, Opening the Door to Avastin Use in AMD   The High Court in London has ruled that the National Health Service (NHS) can use Roche’s Avastin on an off-label basis to treat wet age-related macular degeneration (AMD). In siding with the NHS over AMD drug developers Bayer and Novartis, the judge stated that organization...
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    European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States. That marks a change in the policy Swissmedic established whe...
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    European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Pilots Changes to Accelerate Drug Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year be...
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    European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Revises Pharmacovigilance Guideline After Danish Regulators Spot 'Big Problem' The European Medicines Agency (EMA) has revised its good pharmacovigilance practice (GVP) guideline after Danish regulators flagged up a “big problem” with a draft version. EMA's change mitigates the risk of marketing authorization holders (MAHs) and national agencies independently mergi...