Tag: TGA
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TGA seeks advisory committee members
10 Jul 2018
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10 July 2018: The Therapeutic Goods Administration (TGA) has opened a call seeking expressions of interest from professionals in relevant scientific and medical fields to fill statutory advisory committee vacancies. -
TGA opens annual stakeholder survey
28 Jun 2018
Read More28 June 2018: Industry is invited to take part in the Therapeutic Goods Administration’s (TGA’s) 2018 stakeholder survey, along with other stakeholders including health professionals, the medical products industry, academics and consumers. -
TGA releases revised Australian Clinical Trial Handbook
29 Mar 2018
Read More29 March 2018: The Therapeutic Goods Administration has advised of a major update and re-structure of the Australian clinical trials handbook which provides policy guidance on the clinical trials schemes administered by the TGA. -
TGA commences priority review for medical devices
25 Jan 2018
Read More25 January 2018: Expected to improve dramatically time-to-market, a new priority designation process for eligible medical devices has opened with guidance documents from the Australian Therapeutic Goods Administration (TGA). -
AusBiotech to submit on TGA Amendment Bill Senate Inquiry
19 Dec 2017
Read More19 December 2017: The Senate has referred the most recent TGA Amendment Bills for Inquiry, delaying the implementation of a raft of recommendations of the Medicines and Medical Devices Regulation Review (MMDR). -
TGA progresses Provisional Approval pathway for medicines
9 Nov 2017
Read More9 November 2017: The Therapeutic Good Administration (TGA) has released draft guidance documentation for the Provisional Approval pathway for prescription medicines that is currently being developed in response to recommendations of the Medicines and Medical Devices Regulation Review. -
AusBiotech agrees on up-classification of surgical mesh
10 Oct 2017
Read More10 October 2017: AusBiotech and its AusMedtech Regulatory Affairs Expert Panel have made a submission to the TGA in full support of the recommendation to up-classify surgical mesh products to align with the revised European regulations. -
TGA releases new Uniform Recall Procedure
5 Oct 2017
Read More5 October 2017: A new Uniform Recall Procedure for Therapeutic Goods 2017 (URPTG) (V2.0, October 2017) has been released for a “familiarisation period”, with the revision due to come into effect on Monday 15 January 2018. -
Industry feedback requested on e-form and managing variations
22 Jun 2017
Read More22 June 2017: The Therapeutic Goods Administration (TGA) is working to implement an electronic application form for prescription medicines and a notification process for very low-risk changes to registered medicines, and is seeking feedback from industry stakeholders. -
Support for SMEs to navigate TGA regulations
13 Jun 2017
Read More13 June 2017: Greater support for navigating Australia’s therapeutic goods regulation is now available for SMEs with SME Assist, a new TGA service, launched on Friday by the Minister for Health, the Hon. Greg Hunt MP. -
TGA approval for Orthocell's cartilage repair therapy
1 Jun 2017
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Regenerative medicine company Orthocell has announced TGA approval of Ortho-ACI, the company's autologous chondrocyte implantation fro cartilage repair and regeneration. -
Parliamentary hold-up impacts TGA review changes
25 May 2017
Read MoreImplementation of some key changes announced as part of the review of medicines and medical devices regulation will likely be delayed. -
AusBiotech endorses changes for accessing unapproved therapeutic goods
4 Apr 2017
Read MoreAusBiotech has made a submission endorsing proposed changes to improved access options for unapproved therapeutic goods, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants. -
Senate committee backs TGA reforms
28 Mar 2017
Read MoreSenate backing for legislation giving effect to government’s response to the review of medicines and medical device regulation is all but assured after a Senate Inquiry recommended the Bill be passed. -
TGA reforms one step closer
21 Mar 2017
Read MoreLegislation giving effect to government’s response to the review of medicines and medical device regulation is one step closer after last Friday’s public hearing of the Senate Inquiry. -
TGA seeks feedback on support needs for SMEs
21 Mar 2017
Read MoreThe TGA is investigating ways that it might provide support for small and medium enterprises (SMEs) in accessing regulatory guidance, and seeks feedback on the key themes that emerged in initial discussions with AusBiotech and industry. -
Submission to Senate Inquiry seeks support for TGA Bill
9 Mar 2017
Read MoreAusBiotech had made a submission to the Senate Inquiry on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, urging that the Bill be supported to enable regulatory reform measures stemming from the review of Medicines and Medical Devices Regulation (MMDR). -
TGA approval for CSL Behring lung therapy
28 Feb 2017The TGA has approved CSL Behring’s ZEMAIRA for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
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TGA Bill to cut 'red tape' stalls for Inquiry
14 Feb 2017
Read MoreThe passage of a legislative bill to enable regulatory reform measures stemming from the review of Medicines and Medical Devices Regulation (MMDR) was last week delayed with its referral for Inquiry. -
AusBiotech backs TGA bill to cut red tape
9 Feb 2017AusBiotech backs regulatory reform and the reduction in the burden of ‘red tape’, expressing support for The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2017.
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AusBiotech represents industry in Regulatory Review forums
11 Aug 2015
Read MoreAusBiotech, last week, represented the industry at invitation-only forums, held by the Deregulation Branch of the Federal Department of Health to discuss the first report on the review of medicines and medical devices regulation, which was released on 31 March 2015. -
Feds announce Expert Review of Medicines and Medical Devices Regulatio
28 Oct 2014
Read MoreFurther to the recent launch of the Industry Innovation and Competitiveness Agenda, the Federal Government has announced the establishment of an independent panel to undertake a review of medicines and medical devices regulation in Australia.