Regulatory Update
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25 March 2013
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Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe have announced that a new over–the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be
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Regulatory Update
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20 March 2013
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Australia’s Therapeutic Goods Administration (TGA) has posted new guidance reclassifying joint replacements such as hip, knee and shoulder replacement devices.Under the new guidance, applications to
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Regulatory Update
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8 March 2013
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In the latest collaboration since Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products,
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Regulatory Update
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6 February 2013
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Australia’s Therapeutic Goods Administration (TGA) has issued guidance regarding the types of evidence that must be submitted by companies to meet the conformity assessment requirements for the
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3 December 2012
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High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition
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3 December 2012
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Australia’s Therapeutic Goods Administration (TGA) is implementing the Medical Device Single Audit Program (MDSAP), which aims to strengthen existing international cooperation in the field of medical
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29 November 2012
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The planned merger of the regulatory authorities of Australia and New Zealand continues according to plan, both agencies said in an announcement on 29 November 2012.Australia's Therapeutic Goods
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Regulatory Update
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19 November 2012
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The Australian Government has created a new advisory body for the Therapeutic Goods Administration (TGA) with the mandate to advise TGA on communication with stakeholders, on new agency management
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Regulatory Update
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6 November 2012
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Australia’s Therapeutic Goods Administration (TGA) has reviewed the comments submitted on its Medicines Labeling and Packaging Review Consultation Paper, released in May 2012, and has identified six
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15 October 2012
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Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products
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