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  • Regulatory NewsRegulatory News

    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...
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    Biopharma industry urges MRA to mitigate risk of no-deal Brexit

    The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...
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    EU Regulatory Roundup: Noncompliance actions against Indian drugmakers drop to new low

    The number of European manufacturing noncompliance notices sent to Indian drugmakers fell to a new low last year, with just one good manufacturing practice (GMP) notice issued to an Indian company in 2019 compared to at least five annually over the previous four years, the European Medicines Agency (EMA) reported.   Indian drugmakers received a significant minority of all the GMP noncompliance notices issued by regulators in the European Economic Area (EEA) from 2015 t...
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    Asia Regulatory Roundup: Industry respondents urge TGA to align with international software regulations

    Respondents to a consultation by Australia’s Therapeutic Goods Administration (TGA) on the scope of regulations governing software as a medical device (SaMD) offered broad support for the regulatory scheme and the concept of carving out certain products to avoid undue regulatory burden, the administration reported on 15 June.   TGA held a consultation on the topic earlier this year, specifically to gather feedback on the types of software-based products that should and...
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    EU Regulatory Roundup: MHRA puts speed-to-market at center of post-Brexit vision

    Speed-to-market is the cornerstone of the 2020-2021 post-Brexit strategy for the UK Medicines and Healthcare products Regulatory Agency (MHRA), according to the agency’s business plan published 10 June 2020.   The UK left the European Union earlier this year but remains covered by its rules until the end of 2020. Unless the UK and EU agree to a delay by the end of June, the two parties will fully separate at the start of next year. Exactly how the separation happens wi...
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    Asia Regulatory Roundup: Medtech firms push back against TGA essential principles reform

    Australia’s Therapeutic Goods Administration (TGA) is reconsidering some aspects of proposed reforms to its essential principles for medical device safety and performance due to opposition from medtech organizations including Johnson & Johnson.   In September, TGA outlined plans to incorporate International Medical Device Regulators Forum (IMDRF) essential principles and European Union General Safety and Performance Requirements (GSPRs) into its own regulatory framewor...