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    EU Regulatory Roundup: UK Government Resists Calls to Commit to EMA in Brexit Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Resists Calls to Commit to EMA in Brexit Legislation   The UK government has held off attempts by the House of Lords to shape its approach to the European Medicines Agency (EMA) and regulatory standards after Brexit.   Members of the House of Lords proposed multiple amendments to Brexit legislation related to EMA. One amendment called on the govern...
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    Asia Regulatory Roundup: TGA Proposes Fee Changes to Offset Increase in Costs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Fee Changes to Offset Increase in Costs   Australia’s Therapeutics Goods Administration (TGA) is planning to raise its fees and charges to offset a forecast AU$7 million ($4.8 million) spending increase. TGA’s preferred option is to increase all fees by 1.95%, an indexation factor calculated by looking at changes in wages and consumer prices.   In th...
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    EU Regulatory Roundup: Swissmedic Streamlines Approval Process for Infectious Disease Vaccines

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Streamlines Approval Process for Infectious Disease Vaccines   The Swiss Agency for Therapeutic Products (Swissmedic) has changed its approach to authorization of innovative products to prevent communicable diseases. Having made the change, Swissmedic will allow companies with vaccines already approved in the European Union or United States to follow a st...
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    Asia Regulatory Roundup: TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires   Australia’s Therapeutic Goods Administration (TGA) has cleared pharmacies to advertise puffers and other salbutamol inhalers during the bushfires affecting the country. The temporary relaxation of the advertising restrictions is intended to help spread information about the availability of inhalers...
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    EU Regulatory Roundup: Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs   The Dutch Medicines Evaluation Board (MEB) is hiking up the fees for some medical device services. MEB will now charge €9,000 ($10,000) for consultations on certain medical devices, up from €4.050 under the old fee schedule.   MEB took the action after concluding current fees for device consultatio...
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    Asia Regulatory Roundup: India Gives Device Manufacturers Another Year to Meet Drug Regulations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Gives Device Manufacturers Another Year to Meet Drug Regulations   India has extended the transition to new rules for certain medical devices by 12 months. Regulators were due to start treating a clutch of devices as drugs on 1 January, but have given the industry more time to adapt.   Details of plans to treat more devices as drugs for regulatory purposes,...
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    EU Regulatory Roundup: Finland Prepares for 2020 Introduction of New Clinical Trial Regulations

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Seeks Feedback on Tracking Drug Safety in Pregnancy and Breastfeeding   The European Medicines Agency (EMA) is seeking feedback on its draft good pharmacovigilance practice (GVP) guideline. The draft covers specific considerations for dealing with adverse events in pregnant and breastfeeding women.   EMA wrote the GVP guideline in light of the fact pregnant ...
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    Asia Regulatory Roundup: Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch   TGA has warned that Australia has run out of Mylan’s epinephrine injection EpiPen Jr. A shipment from the US is due to arrive around 17 December, meaning EpiPen Jr will be unavailable in Australia for close to two weeks.   Mylan alerted the Australian public to a shortage of EpiPen Jr last m...
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    EU Regulatory Roundup: HPRA Reduces Fee Increase After Pushback from Industry

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   HPRA Reduces Fee Increase After Pushback from Industry   Ireland’s Health Products Regulatory Authority (HPRA) has reduced its 2020 fee increase in the face of pushback from industry groups. HPRA will now enact a general fee increase of 2%, rather than the previously planned 3%.   In October, HPRA proposed increasing all human medicine, compliance, blood, tissu...
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    Asia Regulatory Roundup: China’s NMPA Finds Fault With Quality Management Systems at Vaccine Facilities

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Blames Misunderstanding for Pushback Against 3D-Printed Device Proposals   Australia’s Therapeutic Goods Administration (TGA) has blamed some of the criticism of its ideas for regulating 3D-printed medical devices on a misunderstanding. TGA thinks respondents misconstrued the details of proposals including its plans to create a new product category called medical...
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    Asia Regulatory Roundup: China Opens Food and Drug Center of Excellence

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Suspends Ranitidine Medicines Ahead of Possible License Cancellations   The Therapeutic Goods Administration (TGA) has suspended 23 ranitidine medicines from the Australian Register of Therapeutic Goods (ARTG). TGA suspended the products for six months but thinks there are grounds to ultimately cancel the medicines from the ARTG altogether.   Last month, TGA ...
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    EU Regulatory Roundup: Swissmedic Creates Signal Notification Form in Change to 2020 Requirements

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Seeks Industry Input on Regulatory Plan Through to 2025   Ireland’s Health Products Regulatory Authority (HPRA) is seeking feedback to inform development of its strategic plan for 2021 to 2025. HPRA wants input on how the sectors it regulates will change in the next five to 10 years and feedback on how well it currently communicates with stakeholders.   ...