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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: Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges   Ireland’s Health Products Regulatory Authority (HPRA) is planning to introduce new fees and increase existing charges. HPRA framed the fee increases in light of the increasingly challenging environment in which it operates, pointing to Brexit, new medical device rules and an increase in the complexit...
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    EU Regulatory Roundup: EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs   The European Medicines Agency (EMA) has asked manufacturers of medicines made with chemically synthesized active pharmaceutical ingredients (APIs) to test their products for nitrosamines. EMA’s request follows the discovery of the carcinogenic contaminants outside the sartan class of drugs. ...
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    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...
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    EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work   The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.   Pascal Ca...
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    EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System   Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.   When the FMD safety feature requirements ca...
  • European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (4 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news . Ireland Offers to Waive Certain Fees to Ease Impact of Brexit Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to Ireland for free. Officials from the Health Products Regulatory Authority (HPRA) of Ireland made the offer in guides on ...
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    European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Gathers Global Drug Agencies, NGOs to Explain its Regulatory System The European Medicines Agency (EMA) is meeting with medicine agencies and non-governmental organizations (NGOs) to explain its regulatory system. EMA sees the education initiative helping other global regulators understand its system and, by extension, more effectively collaborate with its staff. ...
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    European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (17 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Ireland Creates Innovation Office to Provide Regulatory Advice The Health Products Regulatory Authority (HPRA) of Ireland has created an Innovation Office to give advice to developers of novel health products and technologies. HPRA sees the office facilitating the timely development of innovative interventions by providing regulatory input early in the process. Staff ...