Who's a sponsor under the Therapeutic Goods Act?
How many sponsors can a therapeutic good have? The recent decision of Hui v Lane [2003] SASC 401 (11 December 2003) states that there can be more than one sponsor at different points in time, raising...
View ArticleExperimental use under the microscope
Should there be an express exemption in the Patents Act so that the experimental use of patented inventions is not an infringement of the patent?
View ArticleThe impact of the US FTA on the generic pharmaceutical industry & the PBS
The Australia-US FTA was accompanied by media reports and public statements that it would cause the sky to fall on the PBS and Australian generics, but Nicholas Tyacke wonders if they were right.
View ArticleLife Sciences Insights
This issue includes: Future regulation of cell and tissue therapies; ALRC report: gene patenting and human health; Proposed changes to medicine labelling requirements following the Pan recall; ASX...
View ArticleRamifications for Pharmaceutical and Biotech Patent Owners of the...
The legislation implementing the Australia/US Free Trade Agreement ("FTA") came into force on 1 January 2005. The implementing legislation makes certain consequential amendments to Australia's...
View ArticleTGA Initial Discussion paper - Improving access to prescription medicines...
No doubt you are aware that the Therapeutic Goods Administration ("TGA") recently engaged the services of mpconsulting to provide advice to the TGA on the most appropriate means for improving consumer...
View ArticleLatest on web-based access to prescription medicines information
The Therapeutic Goods Administration recently engaged the services of mpconsulting to provide advice to the TGA on the most appropriate means for improving consumer and professional access to web-based...
View ArticleLife Sciences Insights
This issue includes: Government signals tighter regulation of complementary medicines; Clinical trials under the Microscope; Proposed new model for the scheduling of medicines and poisons; Quick dose;...
View ArticleTGA gets set to get tough
The Therapeutic Goods Amendment Bill 2005 ("the Bill") has just been tabled in the Federal Parliament. When enacted, the provisions will significantly expand the powers of the Therapeutic Goods...
View ArticleA possible new approach to funding health care
Australia is spending progressively more on health care. Over coming decades, increasing health costs will place the financial sustainability of the health system under growing pressure.
View ArticleA strong dose of regulation set to shake up pharmaceuticals sector
Companies operating in the pharmaceuticals and medical devices sectors will be forced to review their business practices if proposed changes to the regulatory regime under which they operate are passed...
View ArticleLife Sciences Insights
This issue includes: The TGA gets set to get tough: Likely new enforcement options; Code 2005: The first Australian regulatory step towards a trans-Tasman scheme; Advertising prices of prescription...
View ArticleClayton Utz partner joins Metabolic board
The appointment of Clayton Utz life sciences partner Robyn Baker to the board of Melbourne-based biotech Metabolic Pharmaceuticals Limited as a non-executive director confirms widespread recognition of...
View ArticleLife Sciences Insights
This issue includes: Transparency reforms to the Pharmaceutical Benefits Scheme introduced under the FTA; Food/therapeutic goods interface: Can apples be compared to orange pills?; Quick dose; 8 rules...
View ArticleTherapeutic Goods Amendment Bills: Delayed until next year.
In its final parliamentary session this year, the Senate deferred voting on the Therapeutic Goods Amendment Bill 2005 and the Therapeutic Goods Amendment Bill (No.2) 2005. Both Bills remain at the...
View ArticleLife Sciences Insights
This issue includes: The Australian consumer product safety system - if it ain't broke, should we fix it?
View ArticleLife Sciences Insights
This issue includes: Australia New Zealand Therapeutic Products Authority - Full steam ahead; The NHMRC Amendment Bill 2006 - greater autonomy and transparency; Can you patent a method of medical...
View ArticleBe prepared! New TGA enforcement powers start soon
Australia now has a strengthened regime within the Australian therapeutic goods market including a tiered regime of criminal offences and civil penalties, higher penalties, and liability for "executive...
View ArticleA strong dose of regulation for pharmaceuticals sector
Companies operating in the pharmaceuticals and medical devices sectors will need to be extra vigilant in maintaining good business and risk management practices following changes to the regulatory...
View ArticleLife Sciences Insights
This issue includes: STOP PRESS!; Consultation Forums on ANZTPA Held - Implications of the Joint Scheme for Industry; Wrongful life claims - recent decisions and the implications for the life sciences...
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