RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
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    EU Regulatory Roundup: Denmark permits remote SDV during pandemic

    Extraordinary measures guidance from the Danish Medicines Agency (DKMA) now has been updated to allow remote source data verification (SDV) for certain clinical trials during the COVID-19 pandemic.   Remote SDV enables sponsors to verify data without sending a clinical research associate to a clinical trial site, making it an attractive option at a time when contract research organizations are reporting limited in-person access to study centers. Despite that, the first...
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    Asia Regulatory Roundup: TGA begins virtual GMP inspections of domestic manufacturers

    Australia’s Therapeutic Goods Administration (TGA) has begun conducting virtual inspections as part of a new approach to oversight of domestic manufacturers during the COVID-19 pandemic.   The coronavirus continues to shape TGA operations even as Australia is starts to relax its lockdown. The plan for handling domestic good manufacturing practices (GMPs) inspections shared this week reflects an assumption that in-person assessments of drug production facilities are lik...
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    EU Regulatory Roundup: MHRA temporarily eases GMP rules

    The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has relaxed its interpretation of good manufacturing practices (GMPs) in light of challenges created by the COVID-19 pandemic.   MHRA’s more flexible approach to GMPs is intended to achieve two goals. Firstly, MHRA hopes to free up quality system capacity to help companies “focus on ensuring continuity of supply using quality risk management principles.” Secondly, the agency intends to “add...
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    Asia Regulatory Roundup: Options for mitigating ventilator shortages

    Guidance from regulatory agencies in Australia and Malaysia intends to help healthcare systems cope with surging demand for ventilators.   The Australian document builds on an existing effort to balance supply and demand by providing regulatory exemptions to domestically manufactured invasive ventilators. As it will take time for companies to capitalize on those exemptions and bring new ventilators to market, Australia’s Therapeutic Goods Administration (TGA) has sha...
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    EU Regulatory Roundup: MHRA offers advice on maintaining and calibrating equipment during lockdown

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on Maintaining and Calibrating Equipment During Lockdown   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance to manufacturers and laboratories that need outside engineers to maintain or calibrate their equipment during the COVID-19 pandemic.   Typically, manufacturers and laboratories ask ext...
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    Asia Regulatory Roundup: NMPA seeks to ensure quality of exports as China becomes key supplier of COVID-19 devices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices   China is stepping up efforts to ensure the safety and quality of exported medical devices. The actions come as countries around the world look to China for equipment for use in the detection, prevention and treatment of the pandemic coronavirus.   With the SARS-CoV-2 outbr...
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    EU Regulatory Roundup: MHRA relaxes GMP rules on drug imports to ease pandemic logistical challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications   The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted Continuous Positive Airway Pressure (CPAP) device developed by organizations including the Mercedes Formula One team. MHRA also shared specifications for a rapidly manufactured CPAP...
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    Asia Regulatory Roundup: TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic   Australia’s Therapeutic Goods Administration (TGA) has shared details of how clinicians can mitigate shortages of ventilators triggered by surging numbers of COVID-19 cases. The agency proposes the modification of devices such as anaesthesia gas machines and production of ventilators ba...
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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...