Continuous Product Quality Reviews and FDA quality metrics Are annual PQRs an old school way of thinking? A few years ago I was working on a non-pharma, large scale ERP project for a multi-national. During the blueprinting stage of the project the executive team’s user requirements were consistent and at no point during the project…
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…
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