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Periodic Safety Update Reports (PSURs) for well-established active substances or the registration of a generic

11 February 2010

Recently, the Office of Prescription Medicines of the TGA decided that the review of a Periodic Safety Update Report (PSUR) is a quite time-consuming activity for the TGA. The TGA has come to the view that the benefits of the routine review of PSURs that have been required following a relatively minor change to the registration of a well-established active substance or the registration of a generic version of a registered product are limited and not justified by the effort expended in their review.

The TGA has therefore decided to vary the conditions of specific registration for the need for the submission to TGA of PSURs that have been required for products in certain categories.

Over the next few months sponsors of medicines who fall into this category will receive a letter varying their specific condition of registration for PSURs. The variation will be to continue to prepare but not to submit the PSUR unless requested by the TGA.

A letter of information regarding this was recently sent to industry associations Medicines Australia, the Generic Medicines Industry Association and AusBiotech.