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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Rethinks Reclassification of Implants After Pushback

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Rethinks Regulatory Reclassification of Implants After Pushback   Australia’s Therapeutic Goods Administration (TGA) has revised its approach to the reclassification of certain medical implants after receiving feedback on its plans. TGA received broad support for some of its proposals, leading it to push ahead with its plans, but criticism of its planned approach...
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    EU Regulatory Roundup: UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan   The United Kingdom government has detailed what it hopes to get out of its Brexit trade deal talks with the European Union. UK officials are seeking multiple provisions intended to facilitate trade in medicinal products, for example by proposing for each side to recognize good manufactu...
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    Asia Regulatory Roundup: Shortage Mitigating Measures Increase After TGA Moves to Mandatory Reporting

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Shortage Mitigating Measures Increase After TGA Moves to Mandatory Reporting   Australia’s Therapeutic Goods Administration (TGA) approved more requests to import medicines from overseas to counter supply disruptions after the adoption of mandatory reporting requirements for potential shortages.   Legislation requiring manufacturers to report shortages and discon...
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    EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Authorizes First Drug Under International Work Sharing Initiative   The Swiss Agency for Therapeutic Products (Swissmedic) has approved a drug under its international work sharing initiative for the first time. Swissmedic authorized Roche’s antiviral Xofluza for sale after working with its peers in Australia and Canada.   Health Canada and Australia’s...
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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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    EU Regulatory Roundup: Accord, Glaxo Issue FMD Alerts Over 2D Barcode Problems

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Accord, Glaxo Issue Falsified Medicines Directive Alerts Over 2D Code Problems   Accord Healthcare and Glaxo Wellcome have shared alerts about issues related to compliance with the Falsified Medicines Directive. The alerts are tied to the information encoded on serialised 2D codes.   Glaxo’s situation, which the drugmaker reported to the United Kingdom’s Medicines...
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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...