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    Asia-Pacific Roundup: TGA revises guidance on clinical evidence for comparable devices

    Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, almost totally rewriting the section on comparable devices including substantially equivalent products.   A comparable device is a product “with related function chosen by the manufacturer to inform the clinical evaluation of the device in question,” according to the new section. The first step in the process is to choose a suitable comparable device. So...
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    Euro Roundup: Trade groups criticize joint HTA plan

    The trade groups EFPIA and MedTech Europe have issued statements criticizing a European Council proposal on joint health technology assessments (HTA), noting that the proposal could lead to greater inefficiency.   The proposed regulation aims to support cooperation between national authorities on the clinical assessment of health technologies. HTAs currently are handled independently by national bodies, with limited voluntary cooperation, causing health technology deve...
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    Asia-Pacific Roundup: TGA seeks feedback on drug shortages

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on proposals to empower the agency to reduce the risk of medicine shortages and mitigate the impact when they do occur.   Information about shortages has improved since January 2019, when it became mandatory for sponsors to inform TGA of supply disruptions for reportable medicines, but ongoing problems with the availability of some products have spurred calls for further changes.   TGA set out...
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    Euro Roundup: MHRA pilot seeks evidence of patient involvement in R&D

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has begun a pilot project to encourage patient involvement in drug development, asking companies that seek approval for new active substances and new indications to provide evidence of “patient involvement activities they undertook when developing their product.”   For now, the project is focused on gathering information. Applicants can choose whether to provide MHRA with the requested information, which...
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    Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases

    Australia’s Therapeutic Goods Administration (TGA) has released guidance documents to support the expansion of self-testing in Australia, addressing clinical performance requirements and risk mitigation strategies for self-tests for seasonal influenza, hepatitis B and C, and chlamydia, gonorrhoea and syphilis.   Australia banned self-testing for serious diseases in 2010. An exception was granted for self-tests for HIV in 2014 but otherwise testing for serious diseases ...
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    Euro Roundup: Swissmedic advises on transition to EU MDR

    The Swiss Agency for Therapeutic Products (Swissmedic) has shared details of how the regulation of medical devices will change in the coming months as the EU Medical Device Regulation comes into effect on 26 May.   In preparation, Swissmedic alerted industry to a notice by Kofam, the Swiss portal for human research detailing how the rules will affect sponsors as well as investigators in medical device clinical trials in Switzerland.   Kofam is advising sponsors wit...
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    Asia-Pacific Roundup: TGA reports positive COVID vaccine safety data, backs use of AstraZeneca jab

    Real-world evidence and monitoring have not detected new safety concerns in Australia’s COVID-19 vaccination campaign, according to a report from the country’s Therapeutic Goods Administration (TGA) which was followed quickly by a statement about international reports of blood clots in recipients of AstraZeneca’s vaccine.   The COVID-19 immunization campaign in Australia is currently fairly small by global standards, with around 164,000 vaccinations as of 14 March. A...
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    Euro Roundup: MHRA sets guidance on importing medicines into Northern Ireland

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the importation of medicines into Northern Ireland before 31 December, in response to a European Commission notice on “markets historically dependent on medicines supply from or through Great Britain.”   As part of the Brexit process, European authorities recognized that the historical reliance of Cyprus, Ireland, Malta and Northern Ireland on medicinal products from Great Britain ...
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    Asia-Pacific Roundup: Australia allows pharmacy-level substitution during shortages

    Pharmacists in Australia now may substitute medicines when a patient’s usual treatment is in “serious scarcity” under new legislation that formalizes the Serious Shortages Substitution Notices (SSSNs) officials have used to address supply disruptions since May.   Once TGA publishes a SSSN, pharmacists can dispense substitute medicines per the rules of the notice. Only limited substitutions, such as different doses and dosage forms, are permitted under the scheme.   ...
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    Vaccine makers call for alternative study designs for COVID vaccines

    Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive vice president of Sanofi Pasteur, testified at a joint meeting of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and the Committee on the Environment, Public Health and Food Safety (ENVI).   With over a dozen vaccines authorized or approved around the world, a significant n...
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    Euro Roundup: EDQM clarifies implications of new sartan monographs

    The European Directorate for the Quality of Medicines (EDQM) has explained the implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP).   Last month, EDQM said monographs for five sartan medicines, which were rapidly revised considering the risk of contamination with N-nitrosamines, will take effect 1 April. However, EDQM’s February update lacked details of how the revised monographs will affect suppliers of valsart...
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    Asia-Pacific Roundup: TGA seeks feedback on nanomaterial in medical device regulations

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on the introduction of specific requirements for medical devices containing nanomaterials. TGA is considering adding new definitions and amending essential principles or creating new classification rules.   Materials that range from 1 to 100 nanometers in size are typically considered to be nanomaterials. There are concerns about the impacts of such materials on health and the environment. Tho...