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    Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines

    Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulatory frameworks launched in February 2021.   The PMD special topic describes the nature and type of clinical evidence that is needed to show the performance and safety of the devices, which are personalized for individual patients using t...
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    Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver

    The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all other innovative sectors, according to EFPIA, which expressed deep disappointment in the decision.   Twenty months after India and South Africa proposed an agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on COVID-19 vaccine patents, WTO has finalized the terms of a deal that will a...
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    Asia-Pacific Roundup: India proposes QR codes on key medicines within the year

    India’s Ministry of Health has revived a proposal to add bar codes or quick response (QR) codes to the packaging of 300 top medicines to facilitate product authentication. The requirement is set to come into force at the start of May 2023.   Proposals to include a barcode on drug packaging date back to 2015 when the Indian government released a draft proposal for consultation. The proposal was never finalized because many “pharmaceutical companies showed their inabilit...
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    Euro Roundup: Generic manufacturers ask EU for inflation help

    Leaders at generic drug manufacturers including Sandoz, Teva and Viatris have written to European Union authorities to request actions that enable them to cope with “rampant cost inflation.”   In a letter published by the trade group Medicines for Europe, generic drug manufacturers make the case that the combination of inflation and “policies that continuously lower prices” is unsustainable. Inflation in Europe is above 7% for the first time in decades and the generic ...
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    Asia-Pacific Roundup: PMDA outlines changes to project focused on medicine use in pregnancy

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to a system for promoting the proper use of drugs for pregnant and breastfeeding women. The system went live last month to support the creation of a registry and the digitization of applications.   Officials created the Japan Drug Information Institute in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of medicines on mothers and fetuses. Using the...
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    Euro Roundup: EFPIA warns of ‘critical challenges’ to starting clinical trials that use IVDs

    Sponsors operating in the EU face “critical challenges” when trying to set up clinical trials that require the use of an in vitro diagnostic (IVD), according to officials at EFPIA, who called on the European Commission to address the challenges to avoid damaging the local clinical trial environment.   In the statement, EFPIA (the European Federation of Pharmaceutical Industries and Associations) voiced its full support for the In Vitro Diagnostic Regulation (IVDR), whi...
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    Asia-Pacific Roundup: Philippine FDA consults on accelerated registration of WHO-prequalified products

    The Philippine Food and Drug Administration (FDA) is holding a consultation on its draft implementing guidelines on the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products and vaccines.   WHO issued a collaborative review procedure in 2013, and updated the text in 2016, to enable national regulatory agencies to leverage its scientific assessments to enhance their premarketing evaluation and re...
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    Euro Roundup: Switzerland joins EU in bringing in new IVD requirements to improve patient safety

    The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and post-market surveillance in an aim to improve patient safety.   Switzerland brought IvDO into force on 26 May, the same day as the In Vitro Diagnostic Regulation (IVDR) took effect across the border in the European Union. When Switzerland began work on IvDO, it enjoyed barrier-free mutual market access with ...
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    Asia-Pacific Roundup: TGA updates analytical, clinical performance requirements for seasonal influenza tests

    Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on clinical performance requirements and risk mitigation strategies for seasonal influenza rapid antigen self-tests and combination tests. The second iteration of the guidance features more detailed analytical and clinical performance requirements.   TGA published the original guidance document in March 2021 to help manufacturers benefit from the change in the regulation of self-tests that happ...
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    Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO

    The European Medicines Agency (EMA) is set to suspend around 100 generic medicines that came to market based on data from “flawed” bioequivalence studies run by the contract research organization (CRO) Synchron Research Services.   Officials at the US Food and Drug Administration stopped accepting data from studies by the Indian CRO last year over data integrity concerns. EMA’s Committee for Medicinal Products for Human Use (CHMP) recently completed its own investiga...
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    Asia-Pacific Roundup: Philippine FDA seeks feedback on abridged procedures for clinical trial applications

    The Philippine Food and Drug Administration (FDA) is planning to offer an abridged procedure for clinical trial applications by relying on other regulatory authorities. FDA is running a consultation about its draft guidelines on the proposal for regulatory reliance on the conduct of clinical trials in the Philippines.   It is now more than two years since FDA streamlined its clinical trial regulations. Having made the changes, FDA looked to the World Health Organizatio...
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    Euro Roundup: EMA seeks feedback on remote batch certification post-pandemic

    The European Medicines Agency (EMA) has proposed allowing qualified persons (QPs) to remotely certify batches routinely even after pandemic-related travel barriers are over.   When the pandemic hit, manufacturers operated in business continuity mode and EMA posted guidance on regulatory flexibility to enable companies to minimize the risk of shortages while maintaining high standards of quality, safety and efficacy. EMA recognized that QPs needed to adapt to the pandem...