Paying for registration

Empirical data are rarely suitable for assessing the effectiveness of a system s outcomes and impacts on public health. Nonetheless, certain measures can serve as proxies for evaluating the efficacy of drug regulation. 

The purpose of registration is to assess drugs for efficacy, safety and quality and to ensure that they are of an acceptable standard for use. When similar products are processed, the rates of registration approval and rejection reflect the ability of the registration system to prevent questionable products from gaining market access (3). 

In Estonia, however, as many as 17% of the applications are withdrawn Ifom the process. Rejection rates are highest in Venezuela and Malaysia (30% and 29%, respectively). In both countries, withdrawal rates are small (0% and 3%, respectively). In Australia in particular, the number of applications withdrawn before a final decision has increased significantly in the past four years. This increase in withdrawals is probably a result of the way in which the registration system now operates, with a proposed decision to reject being made by the Delegate, prior to obtaining formal advice from the Australian Dmg Evaluation Committee. 

This section examines the amount of time taken to register a pharmaceutical product— i.e. from the time an application is submitted to the time when the final decision is reached—and attempts to clarify how workload and fees affect registration time. 

Such difficulties are common in comparative studies which use cross-country data. The graphs and discussion should therefore serve purely as an illustration of a conceptual approach for examining how workload, organization and financial factors can affect efficiency. 

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