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MIL-OSI Australia: Product Quality Reviews (PQRs) for listed and complementary medicines

By   /  January 16, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Environment, Exploration, Exports, Gas, Health, KB, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: Product Quality Reviews (PQRs) for listed and complementary medicines

Source: Australian Therapeutic Goods Administration About this guidance This guidance is for manufacturers of listed and complementary medicines manufactured according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP). This guidance is only applicable to manufacturers and sponsors of listed medicines and complementary medicines (including registered complementary medicines). This […]

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MIL-OSI Australia: A warning to consumers about the serious health risks relating to e-cigarette liquid

By   /  January 15, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Health, KB, law, Legal, MIL OSI, Open Source Intel, Pacific Region, United States of America  /  Comments Off on MIL-OSI Australia: A warning to consumers about the serious health risks relating to e-cigarette liquid

Source: Australian Therapeutic Goods Administration The TGA is alerting consumers to the potential risks of purchasing electronic cigarette liquid. This advice stems from a study which found undisclosed and potentially harmful ingredients in electronic cigarette liquid being sold in Australia, including nicotine and traces of other chemicals, in liquid that claimed to be ‘nicotine-free’. Electronic […]

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MIL-OSI Australia: Video: About the Therapeutic Goods Administration

By   /  January 14, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Video: About the Therapeutic Goods Administration

Source: Australian Therapeutic Goods Administration A short video to take you through who we are and what we do. [embedded content] Transcript Show transcript for this video On any given day, our work benefits the health and wellbeing of every Australian. Whether using vitamins or medicines… Or receiving a cutting edge medical treatment… We’re here […]

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MIL-OSI Australia: Consultation: Good Clinical Practice Inspections Program

By   /  January 11, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Therapeutic Goods Administration, Business, Commerce, CTF, DJF, English, Environment, Health, KB, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: Consultation: Good Clinical Practice Inspections Program

Source: Australian Therapeutic Goods Administration This consultation closes on 22 February 2019. Invitation to comment The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Consultation documents Document released for consultation on Friday, 11 January 2019. […]

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MIL-OSI Australia: Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

By   /  January 7, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Therapeutic Goods Administration, Business, Commerce, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Source: Australian Therapeutic Goods Administration This consultation closes on 18 February 2019. Invitation to comment The EU Regulation on medical devices (2017/745) (EU MD Regulation) introduced several amendments, including a number of new and amended definitions and an expanded scope of products that were regulated under the new EU MD Regulation. Having regard to the […]

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MIL-OSI Australia: Webinar: The role of the TGA in digital health

By   /  January 4, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region, Technology  /  Comments Off on MIL-OSI Australia: Webinar: The role of the TGA in digital health

Source: Australian Therapeutic Goods Administration The TGA will be holding a webinar about its role in regulating digital health products. This webinar will be the first of a series planned for 2019 and will be interactive, with the opportunity to ask questions after the presentation. Background information Digital health is a broad, often loosely defined […]

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MIL-OSI Australia: Submissions received and high level summary: Transition to eCTD only for prescription medicines

By   /  January 3, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Environment, Health, KB, MIL OSI, Open Source Intel, Pacific Region, Resource Exploitation, Resource Exploration, Technology  /  Comments Off on MIL-OSI Australia: Submissions received and high level summary: Transition to eCTD only for prescription medicines

Source: Australian Therapeutic Goods Administration Submissions received: Transition to eCTD only for prescription medicines consultation The TGA would like to thank respondents who provided submissions in response to the October 2018 public consultation paper, Transition to eCTD only for prescription medicines. A total of 22 submissions were received. Of those submissions, 19 were from industry […]

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MIL-OSI Australia: Review of the Narcotic Drugs Act 1967 – Public meetings

By   /  December 21, 2018  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Health, KB, Melbourne, MIL OSI, Open Source Intel, Pacific Region, Queensland, Sydney, Trade  /  Comments Off on MIL-OSI Australia: Review of the Narcotic Drugs Act 1967 – Public meetings

Source: Australian Therapeutic Goods Administration Overview The TGA will be hosting three public meetings regarding the Review of the Narcotic Drugs Act 1967. These meetings will take place early in 2019 in Sydney, Brisbane and Melbourne. The dates for the events are set out below, with the venue details in each city to be confirmed […]

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MIL-OSI Australia: 2018 survey results: TGA trusted but not yet a household name

By   /  December 20, 2018  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: 2018 survey results: TGA trusted but not yet a household name

Source: Australian Therapeutic Goods Administration Half of Australians have heard of the Therapeutic Goods Administration (TGA). That is one of the findings of the 2018 TGA stakeholder surveys published today. The TGA conducts surveys each year to seek feedback on our work and better understand the views of our stakeholders. For the first time in […]

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MIL-OSI Australia: Consultation: Remaking Therapeutic Goods Order No. 78

By   /  December 17, 2018  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Therapeutic Goods Administration, Business, Commerce, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: Consultation: Remaking Therapeutic Goods Order No. 78

Source: Australian Therapeutic Goods Administration This consultation closes on 8 February 2019. Invitation to comment The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules and reintroducing pills into the remade Order. Consultation documents Supporting documents Document released for consultation on […]

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