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    Asia Regulatory Roundup: TGA Creates Guidance on Device Standards for Quality Management Systems

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Creates Guidance on Device Standards for Quality Management Systems   The Therapeutic Goods Administration (TGA) has created guidance to help companies comply with a medical device law passed in Australia earlier this year. The law covers medical device standards for quality management systems (QMS) and medical devices intended to be supplied in a sterile state. ...
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    EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit   The European Medicines Agency (EMA) has begun preparing its Clinical Trials Information System (CTIS) for audit. EMA performed testing and bug fixing of the single entry point for clinical trial information earlier in the year, positioning it to now enter “a phase of agile, iterative ...
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    Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days   Australia’s Therapeutic Goods Administration (TGA) has extended its target processing timelines for good manufacturing practice (GMP) clearance applications. TGA will now take up to 120 working days to process compliance verification for sterile and biotech finished products.   GMP cleara...
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    EU Regulatory Roundup: MHRA Offers Advice on use of Brand Names to Prescribe Drugs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on use of Brand Names to Prescribe Drugs   The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.   In some cases, products are appro...
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    Asia Regulatory Roundup: China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners   China is set to tighten restrictions on the use of human materials including DNA, organs, blood and tissues. The rules require foreign organizations to team up with local partners to use human genetic materials and otherwise place extra limits on their access to samples taken in China. ...
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    EU Regulatory Roundup: MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news. MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears   The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has said not to use devices featuring paclitaxel in the routine treatment of patients with intermittent claudication. MHRA took the action after finding the potential mortality risk outweighs the benefits in this pat...
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    Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Reports 25% Fall in Initial Medical Device Registrations   China’s National Medicinal Products Administration (NMPA) has reported a 25% year-on-year drop in initial registrations of medical devices. The fall dragged the overall level of registration activity down to its lowest level since China began publishing data on the topic in 2013.   Last year, NMPA a...
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    EU Regulatory Roundup: Swissmedic Sees Surge in Inquiries as Safety Scares, Brexit Fuel Questions

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Sees Surge in Inquiries as Safety Scares, Brexit Fuel Questions   The Swiss Agency for Therapeutic Products (Swissmedic) has seen a surge in the number of inquiries from the public and specialists. Swissmedic attributed the trend to concerns about quality problems such as the valsartan scandal and uncertainty about the consequences of Brexit.   In 201...
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    Asia Regulatory Roundup: China Approves Amgen and GSK Products Under Overseas Fast-Track Scheme

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Philippine FDA Shares Draft Rules on Clinical Trial Conduct for Comment   The Philippine Food and Drug Administration (FDA) has issued draft regulations on the conduct of clinical trials. The document sets out general principles covering clinical trials run in the Philippines, as well as more specific points addressing each step from application to termination.   ...
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    EU Regulatory Roundup: EMA’s PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz   The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of cough medicines containing fenspiride from the European market. PRAC made the recommendation at a meeting at which it also placed temporary restrictions on the use of Pfizer’s Xeljanz. ...
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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...