The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates, which tracks regulatory, policy and health technology assessments around the world for biopharma and medical device executives.

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The previous issue of the Emerging Markets Regulatory Tracker appeared here: ([A#28131129003]).

Australia Adverse Drug Events Reported In 2012

The Office of Product Review (OPR) at Australia’s Therapeutic Goods Administration (TGA) submitted TGA’s contribution to the Department of Health’s Australian Statistics on Medicines for 2012, which focused on adverse event reporting. According to TGA, it received approximately 14,300 reports of adverse events in 2012, with 57% submitted by pharmaceutical companies, 11% by hospitals (including hospital pharmacists), 5% by general practitioners, 13% by State and Territory health departments, 7% by community pharmacists and 4% by consumers. TGA encourages reporting by all concerned of all suspected adverse events related to medicines that are available in Australia, including prescription medicines, vaccines, and over-the-counter and complementary medicines. The sponsors of medicinal products are required to report adverse events to TGA.

Nanotech Safety Is Key To Brazil’s Industrial Policy

A workshop on nanotechnology safety hosted by Brazil’s national regulator Anvisa and the Brazilian Agency for Industrial Development (ABDI) brought together researchers, government and industry in Brasilia Dec. 3. The purpose of this second in a series workshop was to strengthen Brazil’s capacity for innovation and international competition in the field of nanotechnology. According to Anvisa Center for Education, Research and Knowledge Head Daniella Guimarães de Araújo, research related to potential nanotechnology risks is critical to the agency’s mission of public health protection. ABDI Director Maria Luisa Campos Machado Leal underscored the importance to research and development of nanotechnology products in Brazil of developing appropriate in vivo testing procedures to assess product safety.

Emerging Markets Regulatory Tracker: Australia, Brazil (Vol. 3 No. 79)

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