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    Asia Regulatory Roundup: TGA Mulls Regulatory Reforms for 3D-Printed Devices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Mulls Regulatory Reforms for 3D-Printed Devices   The Therapeutic Goods Administration (TGA) of Australia has proposed introducing a comprehensive package of regulatory reforms in response to the emergence of custom-made medical devices. Under the proposed plan, TGA would form a framework for the regulated production of devices by healthcare providers and otherwi...
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    Asia Regulatory Roundup: India Commits to Phased Overhaul of Medical Device Regulations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Commits to Phased Overhaul of Medical Device Regulations   The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law that will increase oversight of all medical devices on 1 April but will defer enforcing the new requirements for upward of 18 months.   Last year, the Indian ...
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    EU Regulatory Roundup: EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers   The European Medicines Agency (EMA) is preparing to restart activities it paused as part of its move from London to Amsterdam. However, with EMA suffering the highest rate of staff turnover in its history, the work will be spread across a smaller number of employees than in the past.   EMA st...
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    Asia Regulatory Roundup: China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment   China’s National Medical Products Administration (NMPA) is fast tracking the processing of requests to manufacture and sell face masks and other pieces of medical equipment capable of slowing the spread of the coronavirus.   NMPA has created the fast track to encourage manufacturers of ...
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    EU Regulatory Roundup: US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   US Embassy Sounds Alarm About Dutch Compounding of Patented Drugs   The US Embassy in the Netherlands has warned the Dutch government’s policies may “undermine” intellectual property rights for medicines.   Last year, the Netherlands passed legislation to permit pharmacists to prepare patented medicines despite the presence of intellectual property that otherwis...
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    Asia Regulatory Roundup: China’s CDE Limits Face-to-Face Interactions to Curb Spread of Coronavirus

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China’s CDE Limits Face-to-Face Interactions to Curb Spread of Coronavirus   China’s Center for Drug Evaluation (CDE) has taken steps to limit face-to-face interactions between its staff and people at the companies it regulates. CDE initiated the changes in response to the control measures implemented by the Chinese government to curb the spread of the coronavirus ou...
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    EU Regulatory Roundup: Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019   A survey of community pharmacists in 24 European Union countries has found drug shortages got worse across the region last year. Almost 90% of respondents said the situation deteriorated in 2019, showing why regulators including DKMA have made tackling drug shortages a priority.   Accor...
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    Asia Regulatory Roundup: China’s NMPA Steps up Oversight of Epidemic Prevention and Control Products

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China’s NMPA Steps up Oversight of Epidemic Prevention and Control Products   China’s National Medical Products Administration (NMPA) is encouraging its regional outposts to step up their oversight of manufacturers of products intended to prevent and control epidemic infections. NMPA’s statement comes as a deadly coronavirus spreads across China.   The threat pos...
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    EU Regulatory Roundup: UK Government Resists Calls to Commit to EMA in Brexit Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Resists Calls to Commit to EMA in Brexit Legislation   The UK government has held off attempts by the House of Lords to shape its approach to the European Medicines Agency (EMA) and regulatory standards after Brexit.   Members of the House of Lords proposed multiple amendments to Brexit legislation related to EMA. One amendment called on the govern...
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    Asia Regulatory Roundup: TGA Proposes Fee Changes to Offset Increase in Costs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Fee Changes to Offset Increase in Costs   Australia’s Therapeutics Goods Administration (TGA) is planning to raise its fees and charges to offset a forecast AU$7 million ($4.8 million) spending increase. TGA’s preferred option is to increase all fees by 1.95%, an indexation factor calculated by looking at changes in wages and consumer prices.   In th...
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    EU Regulatory Roundup: Swissmedic Streamlines Approval Process for Infectious Disease Vaccines

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Streamlines Approval Process for Infectious Disease Vaccines   The Swiss Agency for Therapeutic Products (Swissmedic) has changed its approach to authorization of innovative products to prevent communicable diseases. Having made the change, Swissmedic will allow companies with vaccines already approved in the European Union or United States to follow a st...
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    Asia Regulatory Roundup: TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires   Australia’s Therapeutic Goods Administration (TGA) has cleared pharmacies to advertise puffers and other salbutamol inhalers during the bushfires affecting the country. The temporary relaxation of the advertising restrictions is intended to help spread information about the availability of inhalers...