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    Euro Roundup: EMA chief calls for extra staff to handle growing workload

    The executive director of the European Medicines Agency (EMA) has told politicians her teams need more support to cope with COVID-19 and their soon-to-be-extended mandate.   At a meeting of a European Parliament committee, Emer Cooke addressed questions about whether EMA has enough staff and money to handle its existing workload and the additional activities created by legislation that puts the agency at the heart of a push to strengthen the region’s health security ...
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    Asia-Pacific Roundup: TGA defies medtech industry by retaining definition of central circulatory system

    Australia’s Therapeutic Goods Administration (TGA) is keeping its definition of the central circulatory system (CCS) despite universal support for change among medtech respondents to a consultation.   Early this year, TGA sought feedback on plans to remove iliac arteries from the CCS definition. The proposal was intended to align TGA with the definition used in the European Union. By aligning with the regulatory bloc, TGA aimed to decrease the regulatory burden on spon...
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    Asia-Pacific Roundup: TGA changes medicinal cannabis approval process, plans further reforms

    The Therapeutic Goods Administration (TGA) has revised the process for applying to supply medicinal cannabis products under Australia’s Special Access Scheme (SAS) and Authorised Prescriber scheme. TGA made the changes after holding a consultation that also convinced it of the need for other, more substantive reforms of the approval process.   In the first set of changes, which took effect on Monday, TGA dropped the need to file Therapeutic Goods (Standard for Medicina...
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    Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union to take the lead on the reform of the World Trade Organization (WTO). The pharma trade group sees the 12th ministerial WTO conference as a chance to reform the international trading system and boost the world’s ability to respond to health crises.   As EFPIA sees it, trade played a key role in the response to COVID-19 and the development of the vaccines that c...
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    Euro Roundup: EU extends scope of guideline on clinical trials with genetically modified human cells

    The European Union has extended the scope of its good practice guideline on the assessment of the genetically modified organism (GMO)-related aspects of clinical trials that study human cells. Officials have revised the text to cover human cells genetically modified without viral vectors and genome edited cells.   Developers cannot use the document to determine whether cells that are genetically modified without the use of viral vectors are classified as GMOs, with off...
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    Asia-Pacific Roundup: CDSCO grants flexibility to ease transition to new device requirements

    India’s Central Drugs Standard Control Organization (CDSCO) has set out the revised timelines for the move of some devices to a new regulatory framework. CDSCO had originally planned to transition the devices to the drug regulatory framework in April, but the move was delayed by COVID-19.   With manufacturers of the CT scanners, implantable devices, MRI equipment and other products affected by the change calling for more time, CDSCO agreed the disruption caused by COVI...
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    Euro Roundup: EU Parliament and Council reach provisional agreement to strengthen EMA

    The European Parliament and Council have reached a provisional agreement on changes intended to improve the management of future health crises and shortages of drugs and medical devices.   One year ago, the European Commission adopted a legislative proposal designed to strengthen the region’s health security framework and reinforce the role of key agencies. The European Medicines Agency (EMA) was a focal point of the proposals, with the Commission setting out plans to ...
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    Asia-Pacific Roundup: India seeks feedback on creating regulatory framework that supports innovation

    India has proposed regulatory reforms intended to encourage R&D and innovation in the pharma and medtech industries. The proposals are part of a broader plan to make India a leader in drug discovery and innovative medical devices by establishing an entrepreneurial environment in the country.   In working toward the goal, the Department of Pharmaceuticals (DoP) is proposing to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical...
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    Euro Roundup: EMA publishes guideline on running registry-based studies

    The European Medicines Agency (EMA) has released recommendations on key methodological aspects specific to the running of registry-based studies by marketing authorization holders and applicants.   EMA, working through its Patient Registry Initiative and the Cross-Committee Task Force on Registries, has explored ways to improve the use of patient registries to support regulatory decision-making. The project led to a series of workshops that generated recommendations an...
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    Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities

    Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse events, and TGA is concerned that longer-term device failures, such as those involving urogynaecological mesh, may present in different healthcare settings to the original procedure.   The consultation grew out of an investigati...
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    Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

    The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking feedback on its preliminary position.   CHMP officials adopted the opinion on IMI PREFER, an Innovative Medicines Initiative-funded “framework with points to consider when selecting methods for industry, regulators and health technology a...
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    Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

    Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.   TGA has been phasing in requirements for sponsors of implantable medical devices to provide patient information leaflets (PIL) and patient implant cards (PIC) since late 2018. The experience has triggered feedback from consumers, healthcare professionals, surgeons, hosp...