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  • RoundupsRoundups

    Euro Regulatory Roundup: MHRA creates synthetic dataset to support COVID-19 research

    The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has created a synthetic dataset to support development of medical technologies for use in the response to COVID-19.   Developers of machine learning algorithms need health data to validate and benchmark their technologies. However, the strict regulation of even pseudonymised data, and lingering privacy fears related to its use, make it hard and expensive for researchers to access the resource...
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    Asia-Pacific Roundup: TGA plans changes to assistive technology oversight

    Australia’s Therapeutic Goods Administration (TGA) is set to limit its definition of assistive technology to low-risk products to clarify which devices are subject to its oversight. TGA chose the revised definition despite a consultation revealing opposition to the change from some trade groups.   In September, TGA held a consultation to advance reforms proposed by the Expert Panel Review of Medicines and Medical Devices Regulation. The panel called for TGA to remove p...
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    Euro Regulatory Roundup: EMA completes COVID-19 vaccine monitoring infrastructure

    The European Medicines Agency (EMA) has finalized a third contract to complete the build out of its infrastructure for monitoring the safety and efficacy of COVID-19 vaccines and medicines in the real world.   Through the latest agreement EMA has tasked Utrecht University and the University Medical Center Utrecht with coordinating an initiative to collect data on the effect of COVID-19 in pregnancy. The program, called the CONSIGN project, will analyze electronic healt...
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    Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

    Reviews conducted by Australia’s Therapeutic Goods Administration (TGA) found “clear examples” of harm caused by medical software.   TGA searched the medical literature for articles on the safety and efficacy of medical software as part of an assessment of how it regulates the sector. In parallel, the administration reviewed its data, revealing that software faults caused 20% of all medical device recalls over the past five years. While the recalls primarily related to...
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    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
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    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
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    Euro Regulatory Roundup: DKMA allows study drugs to be sent to patients

    Clinical trial sponsors in Denmark can ship investigational medicines directly to study participants under extraordinary measures allowed by the Danish Medicines Agency (DKMA).   Early in the COVID-19 pandemic, DKMA created a document detailing extraordinary measures sponsors can take to mitigate the pandemic’s effect on clinical trials; revisions and expansion over time have resulting in a document with a far wider scope and more lasting impact than the original versi...
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    Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on whether its proposed  standard for serialization and data matrix codes is clear and applies to the right medicines.   As it stands, Australia is yet to mandate serialization or the use of data matrix codes. However, with the European Union adopting data matrix codes and United States track-and-trace law specifying the use of similar two-dimensional codes, TGA has put forward a standard to ensure ...
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    EU Regulatory Roundup: EMA seeks feedback on veterinary antimicrobial plan

    A proposed strategy document from the European Medicines Agency (EMA) would require post-authorization trials of veterinary antimicrobials to ensure the benefit-risk balance of a product remains positive, among other requirements. Such studies could cut the risk of the continued use of products that are driving the evolution of antibiotic-resistant bacteria.   The proposal reflects EMA’s decision to make mitigating the threat posed by antimicrobial resistance a key str...
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    Asia Regulatory Roundup: TGA ties fee increases to inflation, despite medtech opposition

    Australia’s Therapeutic Goods Administration (TGA) is set to increase its fees by 1.95% in its 2020-2021 fiscal year. TGA decided on the fee increase, which is tied to consumer price and wage inflation, despite a consultation revealing opposition from the medtech industry.   In January, TGA held a consultation to gather industry feedback on three options for changing its fees and charges. TGA stated its preferred option was a 1.95% increase, in line with an indexation ...
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    EU Regulatory Roundup: Regulators propose 40 actions to cut risk of medicine impurities

    European regulators have used their experience with the sartan contamination crisis to draw up a list of 40 recommendations for how to stop impurities from making their way into finished medicines.   Last year, members of the European regulatory network began considering the lessons learned from the discovery of N-nitrosamines in sartans and other classes of medicines. After receiving pushback from industry late last year, they have published a list of 40 recommendatio...
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    Asia Regulatory Roundup: COVID-19 drives Australia to propose delay to medical device reforms

    Australian medical device reforms could be delayed until next year to give the industry more time to prepare, considering the effect COVID-19 has had on preparations.   Under the current timeline, Australia would implement a raft of reforms to its medical device rules on 25 August. If enacted, the delay will push the implementation of reforms to the regulation of medical device software and personalized medical devices back to 25 February 2021. The government is also p...