Latest

MIL-OSI Australia: Australian Government response to the Senate Community Affairs References Committee report

By   /  October 10, 2018  /  24-7, Aid, APEC, Asia, Asia Pacific, Asia Pacific Economic Cooperation (APEC), Asia Pacific Region, Australia, Australian State Governments, Australian Therapeutic Goods Administration, Business, Commerce, Education, English, Exports, Health, law, Legal, MIL OSI, New South Wales, New Zealand, Open Source Intel, Pacific, Pacific Region, Resource Exploitation, Resource Exploration, Technology, Trade, United States of America  /  Comments Off on MIL-OSI Australia: Australian Government response to the Senate Community Affairs References Committee report

Source: Australian Therapeutic Goods Administration Introduction The Australian Government welcomes the Senate Community Affairs References Committee report on the Number of women in Australia who have had transvaginal mesh implants and related matters. The Inquiry has raised awareness of the serious and long standing impacts reported by women following mesh related procedures and strongly identified […]

Read More →
Latest

MIL-OSI Australia: TGA business plan 2018-19

By   /  October 9, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Budget, Business, Canada, Commerce, Education, English, Environment, European Union, Exploration, Exports, Health, Intelligence, law, Legal, Media Intelligence, MIL OSI, Mining, Open Source Intel, Pacific, Pacific Region, Singapore, Technology, Trade, United States of America  /  Comments Off on MIL-OSI Australia: TGA business plan 2018-19

Source: Australian Therapeutic Goods Administration Introduction The Therapeutic Goods Administration (TGA) is part of the Health Products Regulation Group (HPRG) within the Department of Health and is committed to delivering a world class, efficient and timely regulatory system for therapeutic goods. HPRG comprises three divisions, which are supported by the Regulatory Legal Services Branch, the […]

Read More →
Latest

MIL-OSI Australia: Section 7AA instrument

By   /  September 27, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Section 7AA instrument

Source: Australian Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) has made a new determination under section 7AA of the Therapeutic Goods Act 1989 (the Act) which excludes certain goods from the operation of the Act. The instrument takes effect on 1 October 2018. There are three key elements of the new section 7AA instrument […]

Read More →
Latest

MIL-OSI Australia: ‘Meeting your obligations’ workshop

By   /  September 24, 2018  /  24-7, Aid, Asia Pacific, Asia Pacific Region, Australia, Australian Cities, Australian Therapeutic Goods Administration, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region, South Australia, West Australia  /  Comments Off on MIL-OSI Australia: ‘Meeting your obligations’ workshop

Source: Australian Therapeutic Goods Administration Expression of interest We are exploring the possibility of delivering this workshop in Adelaide and would like to gauge your interest. If you would be interested in attending a workshop in Adelaide, please let us know. Expression of interest Who should attend Navigating the regulatory maze can be a challenge, […]

Read More →
Latest

MIL-OSI Australia: NET Remedies homeopathic products

By   /  September 23, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: NET Remedies homeopathic products

Source: Australian Therapeutic Goods Administration Recall – possible microbial contamination Consumers and health professionals are advised that NET Remedies, in consultation with the TGA, is recalling all unexpired aqueous-based products currently in the supply chain due to possible microbial contamination. During a routine audit of the overseas manufacturing facility by the US Food and Drug […]

Read More →
Latest

MIL-OSI Australia: TGA presentations: 2018 ARCS Annual Conference, 21-23 August 2018

By   /  September 14, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region, Sydney  /  Comments Off on MIL-OSI Australia: TGA presentations: 2018 ARCS Annual Conference, 21-23 August 2018

Source: Australian Therapeutic Goods Administration Presentations given by the TGA at the 2018 ARCS Annual Conference, Sydney, 21-23 August 2018 Sessions Session A01 Session A03 Session A05 Session A11 Session A12 Session A13 Session A19 Session A20 Session A24 Session B03 Session B04 Session B05 Session B10 Sessions B12 Session B17 Session B18 Session B19 […]

Read More →
Latest

MIL-OSI Australia: Submissions and TGA response: Miconazole and fluconazole: proposed additional advisory statements for medicines

By   /  September 14, 2018  /  24-7, Aid, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: Submissions and TGA response: Miconazole and fluconazole: proposed additional advisory statements for medicines

Source: Australian Therapeutic Goods Administration The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the consultation: miconazole and fluconazole: proposed advisory statements for medicines. Submissions received How to access a pdf document Five submissions were received. The following submissions provided consent for publication on the […]

Read More →
Latest

MIL-OSI Australia: Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

By   /  September 13, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Source: Australian Therapeutic Goods Administration Scheduling of medicines and poisons Public submissions made in response to: Public submissions on proposed amendments to be referred to an expert advisory committee Public submissions on proposed amendments referred to the ACMS #24 Sildenafil Budesonide Alkyl nitrites Codeine Cannabidiol and tetrahydrocannabinols Ibuprofen combined with paracetamol Public submissions on proposed […]

Read More →
Latest

MIL-OSI Australia: Puritan Bennett 980 Series Ventilator

By   /  September 13, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Education, English, Exploration, Gas, Health, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: Puritan Bennett 980 Series Ventilator

Source: Australian Therapeutic Goods Administration The decision to suspend the PB980 ventilator from the Australian Register of Therapeutic Goods (ARTG) has been revoked. This revocation has occurred following review, by the Therapeutic Goods Administration’s (TGA), of an application for revocation of the suspension from the sponsor, Medtronic. The TGA is also imposing conditions on the […]

Read More →
Latest

MIL-OSI Australia: Faecal Microbiota Transplantation Stakeholder forum

By   /  September 12, 2018  /  24-7, Aid, Asia Pacific, Asia Pacific Region, Australia, Australian Cities, Australian Therapeutic Goods Administration, English, Health, Melbourne, MIL OSI, Open Source Intel, Pacific Region, South Australia, Sydney  /  Comments Off on MIL-OSI Australia: Faecal Microbiota Transplantation Stakeholder forum

Source: Australian Therapeutic Goods Administration The TGA is hosting a stakeholder forum to confirm our understanding of the health care sector engaged in the collection, manufacture and supply of material used in faecal microbiota transplantation (FMT). The forum seeks to clarify if and how the FMT sector can meet the current regulatory requirements for materials […]

Read More →