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    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
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    Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

    MedTech Europe has estimated as few as one-quarter of currently available in vitro diagnostics (IVDs) will be certified under the incoming regulations by the time they take effect next year. The trade group based its forecast on a survey of IVD manufacturers.   Many IVDs will need to be certified by notified bodies for the first time under the new regulations. With a small pool of notified bodies available to do the work, MedTech Europe has repeatedly raised concerns t...
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    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
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    Asia-Pacific Roundup: TGA posts guide to rapid COVID-19 test performance requirements, risk mitigation strategies

    Australia’s Therapeutic Goods Administration (TGA) has provided guidance on performance requirements and risk mitigation strategies for rapid COVID-19 antigen tests ahead of its anticipated move to lift its ban on self-testing.   TGA disclosed plans to publish the guidance earlier this month in a call for expressions of interest in supplying self-tests in Australia. The guidance explains that rapid antigen tests, like the self-tests that Australia already allows unde...
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    Euro Roundup: MHRA revises guidance on remote clinical trial monitoring, EHR access

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on remote access to electronic health records (EHRs) by monitors and the off-site oversight of clinical trial sites during the COVID-19 pandemic.   Last year, MHRA published two guidance documents on the topics. The guidance on access to EHRs by sponsor representatives in clinical trials lacked a discussion of remote direct access to the records. Similarly, guidance on how to man...
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    Asia-Pacific Roundup: TGA takes Medtronic to court over alleged unlawful supply of medical device

    Australia’s Therapeutic Goods Administration (TGA) has begun legal proceedings against Medtronic Australasia over the alleged unlawful supply of the Infuse Bone Graft Kit. TGA is accusing Medtronic of unlawfully supplying 16,290 kits to 108 hospitals between September 2015 and January 2020.   Medtronic registered the kit in the Australian Register of Therapeutic Goods (ARTG) in 2005 for use in spinal fusion procedures in skeletally mature patients with degenerative dis...
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    Euro Roundup: Commission seeks feedback on proposed EudraVigilance changes

    The European Commission is seeking input on planned changes to pharmacovigilance regulations. Based on feedback from the European Medicines Agency (EMA), the Commission is proposing to add rules about EudraVigilance monitoring and contracts with pharmacovigilance service providers.   Overall, the Commission said the experience with the pharmacovigilance implementing regulation is “good.” However, talks with EMA and the Pharmacovigilance Risk Assessment Committee have i...
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    Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

    India’s Central Drugs Standard Control Organization (CDSCO) has deemed 31 fixed-dose combinations (FDCs) as rational some 14 years after India ordered the withdrawal of 294 FDCs only for manufacturers to mount a legal challenge.   Most of the FDCs deemed to be rational in the past week are part of the original 294 products targeted by the Indian authorities. The 31 products were assessed by India’s Drugs Technical Advisory Board (DTAB) and the Kokate Committee set up...
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    Euro Roundup: UK sets up group to involve patients in ILAP pathway

    UK sets up group to involve patients in Innovative Licensing and Access Pathway   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has formed a patient group to support its Innovative Licensing and Access Pathway (ILAP). MHRA set up the group to ensure that “patient views are an integral part of the ILAP ambition.”   UK officials shared details of ILAP late last year, describing how the pathway will accelerate time to market by enabling drug de...
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    Asia-Pacific Roundup: TGA to publish adverse event reports within 14 days

    Australia’s Therapeutic Goods Administration (TGA) has slashed the time it will take to share adverse event reports with the public, publishing the details of adverse events 14 days after accepting them into its database.   Since 2012, TGA has made publicly available the de-identified reports of suspected side effects in its Database of Adverse Event Notifications - medicines (DAEN) 90 days after they are accepted. The lag between acceptance and publication has given T...
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    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...
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    Asia-Pacific Roundup: TGA updates timeframe for prescription medicines registration process

    Australia’s Therapeutic Goods Administration (TGA) has updated the timeframe for the expert advisory review phase of the prescription medicines registration process. TGA is now aiming to send advice to the applicant 10 to 12 working days after the meeting.   The Australian registration process includes the option for the Advisory Committee on Medicines (ACM) or the Advisory Committee on Vaccines (ACV) to provide independent advice on a submission. Under the old TGA gu...