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  • RoundupsRoundups

    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Accelerated Approval Guidelines in Flurry of Activity   The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes.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...
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    Asia Regulatory Roundup: India Plans to Bring All Medical Devices Under CDSCO Oversight in December

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Plans to Bring All Medical Devices Under CDSCO Oversight in December   The Indian government is planning to give the Central Drugs Standard Control Organization (CDSCO) oversight of the import, manufacture and sale of all medical devices in December. If finalized, the change would require many more medical device companies to seek certification and authorizatio...
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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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    Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies   Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.   Work to update the law ...
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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...