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    EU Regulatory Roundup: MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on how to manage clinical trials during the COVID-19 outbreak. With the pandemic and government responses to it disrupting studies, the MHRA guidance offers sponsors advice on how to deal with...
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    Asia Regulatory Roundup: India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics   The Central Drugs Standard Control Organization (CDSCO) of India has unveiled a series of actions designed to accelerate development of drugs, vaccines and diagnostics for use in the management of the COVID-19 pandemic.   Like many of its peers, CDSCO wants to work with developers of ...
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    EU Regulatory Roundup: MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has switched to teleconferencing for scientific advice meetings. MHRA’s new policy is one of several actions taken by European regulatory agencies this week to adapt their operations to the coronavirus outbreak. ...
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    Asia Regulatory Roundup: TGA Partly Suspends Overseas Inspections in Response to COVID-19 Outbreak

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Partly Suspends Overseas Inspections in Response to COVID-19 Outbreak   Australia’s Therapeutic Goods Administration (TGA) has suspended inspections of manufacturers in some countries in response to a travel ban imposed in the country. TGA also warned that restrictions on the travel of inspectors at other regulatory agencies may hinder its ability to perform desk...
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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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    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...