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    Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Extends Timelines for Reporting Medical Device Adverse Events   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.   Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death...
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    Asia Regulatory Roundup: TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls   Australia’s Therapeutic Goods Administration (TGA) has advised physicians about how to manage the shortages created by recalls of ranitidine medicines. The notice follows decisions by eight companies to recall batches of ranitidine medicines in response to contamination concerns.   TGA firs...
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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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    Asia Regulatory Roundup: Australia Suspends Sales of Eight Breast Implants After Safety Review

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Suspends Sales of Eight Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) has suspended the sale of eight breast implants after finishing its review of the safety of the product class. The action gives affected manufacturers a chance to meet patient safety requirements, but TGA thinks there are likely grounds to perman...
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    EU Regulatory Roundup: Feedback Informs EMA Opinion on Novartis eSource Proposal

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Feedback Informs EMA Opinion on Novartis eSource Proposal   The European Medicines Agency (EMA) has finalized its qualification opinion on Novartis’ eSource direct data capture technology. EMA reached its final position after running a public consultation that attracted responses from organizations including Bayer, Bristol-Myers Squibb and Pfizer.   Novartis tr...
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    Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Adopts Risk-Based Model for Fecal Microbiota Transplants   Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.   The model...
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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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    Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs   Australia’s Therapeutic Goods Administration (TGA) has aligned its requirements for sartan medicines with those adopted in Europe. The action coincided with news from Singapore about the presence of N-nitrosodimethylamine (NDMA), one of the key sartan impurities, in GlaxoSmithKline’s Z...
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    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
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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...
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    Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Plan to List Excipients in Drug Products Online   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to list the excipients in medicines online. TGA is considering enforcing the change to give consumers access to information about the products they consume.   Today, the public version of the Australian Register f...
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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...