In early 2017, the United States Pharmacopeial Convention (USP), European Medicines Agency and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) finalised guidelines (ICH Q3D and USP ) containing new permitted daily exposure limits for elemental (inorganic) impurities in pharmaceuticals and dietary supplements. On the 17th of August 2015,…
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration. On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the…
The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, New Zealand only pays $2.01 in comparison to the price paid in Australia of $38.69. The Commission recommends many changes are be…
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
EU guidelines A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Guideline on the requirements for quality documentation…
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