Regulatory agencies, safety issues

Regulatory agencies, safety issues, 745-9 Relative mass response factor, flame ionization detection, 689... 

Reports of reactions occurring in other coim-tries are not required to be routinely submitted to TGA. However, any significant safety issue or action that has arisen from an analysis of foreign reports, or has been taken by a foreign regulatory agency, must be reported to the TGA within 72 h. 

Sponsors are not required, as a matter of routine, to submit individual patient reports to the TGA of suspected adverse drug reactions occurring with use of the same product in another country, even if a trial is ongoing at Australian sites. However, the TGA requires that sponsors advise the Experimental Drugs Section of DSEB within 72 h of any significant safety issue which has arisen from an analysis of overseas reports or action with respect to safety taken by another country s regulatory agency. This advice must include the basis for such action. 

MHRA (Medicines and Healthcare Products Regulatory Agency) (2008) Drug Safety Update, Volume 1, Issue 6, January. Available at http //www.mhra.gov.uk/Public ations/ Safetyguidance/DrugSafetyUpdate/CON2033505 [Accessed 10 April 2008],... 

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