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: MEB becomes a cornerstone of EMA assessments

    The Dutch Medicines Evaluation Board (MEB) has increased its share of European human rapporteur and co-rapporteur cases to become the dominant force in the centralized authorization procedure.   After Amsterdam was identified as the European Medicine Agency’s (EMA) next home, MEB began collaborating with regulators in other Member States to ensure work previously performed by the United Kingdom could be spread across multiple agencies. The initiative was intended to sp...
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    Asia Regulatory Roundup: India acts to stop hoarding of N95 masks, prevent gouging

    The Indian government has ordered companies involved in the supply of N95 face masks to keep the cost of their products down. Officials issued the notice in response to reports of N95 face mask “hoarding, black-marketing and differential higher pricing.”   N95 face masks are classed as an essential commodity under an action the India government took in mid-March. The legislation makes hoarding and black-marketing a punishable offense. Officials have also directed regio...
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    EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine

    Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment.   Concerns about the risks posed by administering hydroxychloroquine to COVID-19 patients have so far primarily focused on the link between the drug and cardiac arrhythmia. However, the history of use of hydroxychloroquine in the treatment of conditions including lupus and malaria shows the ...
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    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
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    Asia Regulatory Roundup: TGA permits limited unlicensed radiopharmaceutical production

    Australia’s Therapeutic Goods Administration (TGA) has relaxed the rules on the production of radiopharmaceuticals in response to the breakdown in interstate commerce during the pandemic.   Under normal circumstances, hospitals can readily source radiopharmaceuticals from manufacturers in other Australian states. However, the COVID-19 pandemic has caused a significant reduction in direct flights between state capitals, making it hard for some hospitals to access short-...
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    EU Regulatory Roundup: Regulators warn on COVID products online

    Regulatory agencies in Finland, France and Switzerland have posted warnings about the online trade in products for diagnosing, preventing and treating infections with the SARS-CoV-2 virus.   The alert shared by the Swiss Agency for Therapeutic Products (Swissmedic) highlighted online sales of chloroquine, a malaria drug with a similar chemical structure to hydroxychloroquine, as an area of concern. Swissmedic sees medicines sold online for use against COVID-19 as a “ma...
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    Asia Regulatory Roundup: CDE posts draft guidance on SARS-CoV-2 antibodies

    China’s Center for Drug Evaluation (CDE) has released technical requirements for developers of antibodies against the pandemic SARS-CoV-2 coronavirus. The guidance provides advice on how to develop and manufacture antibodies capable of stopping the virus from entering cells.   Antibodies have emerged as one of the most keenly anticipated pharmacological responses to the coronavirus, reflecting experience with the modality and summer start dates for a clutch of assets t...
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    FDA creates umbrella emergency pathway for COVID-19 serology tests

    The US Food and Drug Administration (FDA) has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.   Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by FDA on Wednesday gives test developers a ne...
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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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    Study tracks sharp drop in FDA approvals based on 2 pivotal trials

    The proportion of drugs approved by the US Food and Drug Administration (FDA) on the strength of two or more pivotal trials fell by almost 30 percentage points over the past 20 years, according to an analysis published in JAMA Network Open.   Guidance from the late 1980s, when FDA set down its thinking on the data needed to win approval, indicate that at least two late-phase clinical trials were needed. However, FDA has long deviated from that standard in situations – ...
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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...