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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.   ...
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    Asia Regulatory Roundup: TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on the quality standards it plans to impose on manufacturers of fecal microbiota transplant (FMT) products. TGA wants to know how the changes will affect the sector and whether the proposed 12-month transition period is ...
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    EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Database

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EU Health Group Raises Concerns About Delays to Clinical Trial Portal and Database   The European Parliament’s public health committee has raised concerns about the delayed rollout of a clinical trial portal and database. Committee members made the comments shortly after the European Medicines Agency (EMA) provided an update on the repeatedly delayed system.   W...
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    Asia Regulatory Roundup: Industry Questions TGA’s Ability to Enforce Proposed Software Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Medtech Industry Questions TGA’s Ability to Enforce Proposed Software Rules   The medtech industry has questioned whether the Therapeutic Goods Administration (TGA) can ensure all Software as a Medical Device (SaMD) products are included in the Australian Register of Therapeutic Goods (ARTG).   TGA proposed mandating the inclusion of SaMD products in the ARTG when ...
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    EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Trade Group Calls for EU to Cut Review Times for ATMP Clinical Trial Filings   The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants regulatory agencies to cut review timelines and harmonize their approaches to support development of cell and gene therapie...
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    Asia Regulatory Roundup: Pakistan Posts Draft Accelerated Approval Guidances

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pakistan Posts Draft Accelerated Approval Guidelines in Flurry of Activity   The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes. DRAP released the guidelines alongside a clutch of other guidance documents covering topics including pharmacovigilance and post-registration variations.   ...
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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...