Adverse drug reactions product safety

The standard conditions of registration require the sponsor to inform the TGA of any adverse drug reactions and safety alerts related to their product of which they become aware. 

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. 

If this complication occurs, the drug should be withdrawn immediately (7). A report has given some data on the frequency with which tiaprofenic acid cystitis-related disorders were reported to the UK s Committee on Safety of Medicines. Between 1981 and 1996, 770 adverse drug reactions involving 221 patients were reported. A peak in the reporting of cystitis was noted in 1994, when tiaprofenic acid product information was changed and advice was sent to UK doctors warning about cystitis-related... 

In cases when the medicinal product has been registered in other countries, it is desirable to present information on the adverse drug reaction reports collected during the post-registration survey of the medicinal product. If possible, these data shall be discussed in respect to the data for consumption of the medicinal product. It is necessary to attach the publications made on the safety of the medicinal product under registration and the safety of other medicinal products containing the same active substance(s). 

Does the manufacturer monitor the adverse drug reactions, safety and efficacy of the product If yes, relevant data are to be enclosed. 

To evaluate information related to adverse drug reaction for the purpose of providing advice to the Licensing Authority on the safety of medicincd products. 

The sponsor of an IMP or the MA holder in the case of a clinical trial using a licensed medicine is responsible for the ongoing safety assessment, compliance with reporting timelines and distribution of reports to all concerned parties. Furthermore, the sponsor of a trial now also has the responsibility to report serious adverse drug reactions occurring in the use of active comparator products, even if the sponsor of the trial is not its MA holder. The guidelines recommend that the sponsor also inform the MA holder about the reported case. 

Program MedWatch has four purposes. First, to clarify the parameters of what should be reported to the FDA. Second, to increase awareness about serious reactions caused by drugs or medical devices. Third, to help make it easier to report adverse drug reactions. Fourth, to give the health community a continuous feedback mechanism for reporting product safety issues (Henkel, 1999). 

---