Post-registration period

Furthermore, the scientific proof of a negative is virtually impossible when fewer than an infinite number of patients have been studied. The more elusive problem, then, is to define acceptable uncertainty. Some of these decisions are based upon precedent rather than observation. Pharmacoepidemiology is often a useful source of precedents, as well as available for further, future study in the post-approval period to clarify residual questions and/or reduce the remaining uncertainty. While many of the activities described can then be orientated towards support of registration with fair and balanced labeling or education that is useful to the prescriber, recently regulators have requested and sponsors have proposed programs of risk... 

The new fee structure, which sees premarket evaluation fees gradually reducing and post-market annual product registration charges increasing, is being phased in over 5 years. At the end of the transition period, revenue from pre-market evaluations will be 60% rather than 80% under the previous arrangements. The revised structure will make TGA s revenue less vulnerable to fluctuations in number of major applications. 

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