Medical Device Data Systems On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. The guidance document continues to reflect the FDA’s risk management approach around medical devices developed for patient self-monitoring. In June…
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…
Purpose This White Paper on how to “How to list or register a medicine in Australia” is written to assist those interested in the process for approval to supply TGA regulated therapeutic products in Australia. Audience This White Paper is written to assist anyone interested in the planning and execution of regulatory activities to support supply…
This White Paper offer practical advice on “How to list or register a complementary medicine in Australia”, complementary medicines include vitamin, mineral, herbal, aromatherapy and homeopathic products. Products that may be considered to be food supplements or nutritional supplements in other countries are deemed to be complementary medicines in Australia. Multi-vitamin tablets are one such…
Purpose This white paper on “how to register a prescription medicine in Australia” provides an outline of the legal and regulatory requirements and processes for obtaining approval to supply prescription medicines in Australia. It outlines the steps to fulfil the requirements for manufacture and supply of the products and provides practical tips on which path…
eCTD submissions PharmOut dialed in to listen to the eCTD Introductory Meeting on July the 3rd, which was hosted by the TGA in Canberra and was run by John Bell, eCTD Project Manager, TGA and Kent Briggs, Lead Consultant, eCTD Implementation, from LORENZ Life Science. Kent referred to a lot of information already publically available…
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).
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