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    Asia Regulatory Roundup: TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances   Australia’s Therapeutic Goods Administration (TGA) has discussed when it will stop the clock in its handling of complaints about advertising. TGA updated its policy on the same day as it shared new details of its legal case against Peptide Clinics Australia.   The original TGA guide to...
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    Asia Regulatory Roundup: Indian High Court Stays Profiteering Proceedings Against Abbott

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Indian High Court Stays Profiteering Proceedings Against Abbott   The Delhi High Court has hit pause on anti-profiteering proceedings against Abbott. The ruling frees Abbott from the need to pay a fine imposed by the National Anti-Profiteering Authority (NAPA) while the constitutional validity of the punishment is considered.   NAPA fined Abbott Rs 96.59 lakh ($1...
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    EU Regulatory Roundup: Ireland Hires IVD, Medical Device Staff Ahead of EU Legislative Changes

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Hires IVD, Medical Device Staff Ahead of EU Legislative Changes   Ireland’s Health Products Regulatory Agency (HPRA) has begun recruiting for medical device and in vitro diagnostic (IVD) positions ahead of the implementation of Europe-wide legislative changes.   HPRA released advertisements for two positions this week, both of which refer to the incomi...
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    Asia Regulatory Roundup: China Reviews Supervision of Cell and Gene Therapies Through Regulatory Action Plan

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Fining Individuals $15,000 for Drug Shortage Reporting Failings   Australia’s Therapeutic Goods Administration (TGA) will hit individuals who fail to comply with its new drug shortage reporting rules with fines of up to AU$21,000 ($15,000). TGA may fine companies that breach the rules 10 times as much in a bid to ensure compliance with the requirements. ...
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    EU Regulatory Roundup: MHRA Accused of Appalling Treatment of Families in Pregnancy Test Review

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Accused of Appalling Treatment of Families in Pregnancy Test Review   A politician has accused the United Kingdom drug regulator of behaving “appallingly” to families who gave evidence to a panel that assessed the link between hormone pregnancy tests and birth defects or miscarriage.   The accusation against the Medicines and Healthcare product Regulatory A...
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    Asia Regulatory Roundup: WHO Seeks to Help Cambodia Strengthen Drug Regulation

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Posts Guide to Revised Rules on New Drugs and Clinical Trials   India’s Central Drugs Standard Control Organization (CDSCO) has posted a guide to its new drugs and clinical trials rules. The document addresses common questions about the new rules, such as when clinical trial sponsors can benefit from a fast track open to India-focused development programs.   ...
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    EU Regulatory Roundup: France’s ANSM Warns About NSAIDs Following Safety Review

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   France’s ANSM Issues Warning About NSAIDs Following Safety Review   France’s National Agency for the Safety of Medicines and Health Products (ANSM) has published a warning about the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients suffering from infectious diseases. ANSM issued the warning after analyzing almost 20 years of real-world safety data on ...
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    Asia Regulatory Roundup: Korean Gene Therapy Probe Triggers Accusations of Data Fabrication, Lawsuit

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Korean Gene Therapy Probe Triggers Accusations of Data Fabrication, Lawsuit   The publication of an interim analysis of the cells used in the Invossa gene therapy has intensified the pressure on its producer, Kolon Life Science. Following the release of the regulatory report, Kolon had to defend itself against accusations of data fabrication, and a law firm began rec...
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    EU Regulatory Roundup: Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors   The European Commission has published a document detailing the interplay between clinical trial rules and the General Data Protection Regulation (GDPR). The document sets out the data protection requirements of the incoming Clinical Trials Regulation (CTR) and how they interact with GD...
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    Asia Regulatory Roundup: Australia and New Zealand Defer Decision on Potential Breast Implant Ban

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia and New Zealand Defer Decision on Potential Breast Implant Ban   Regulatory agencies in Australia and New Zealand have held off on deciding whether to ban certain breast implants over a link to a form of cancer. The agencies clarified their positions after their peers in Canada and France prohibited the sale of Allergan’s Biocell.   Authorities in Canad...
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    EU Regulatory Roundup: Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans   The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on orphan drugs and pediatric investigation plans (PIPs). The revisions address topics, including orphan drug fees and the documentation to supply in support of European and American PIPs.   Swissmedic’s cha...
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    Asia Regulatory Roundup: China Adds 30 Drugs to Fast Track for Products Approved Overseas

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Reports Jump in Timely Completions of Overseas GMP Inspections   Australia’s Therapeutic Goods Administration (TGA) has improved the on-time rate of its overseas inspection operation. TGA performed 78% of inspections on time over the second half of last year, up from 53% over the corresponding period of 2017.   The agency aims to perform initial good manufact...