The Principles

New drug applications are considered by the Medicines Assessment Advisory Committee (MAAC) which is advisory to the Ministry of Health. The MAAC has traditionally made the recommendations for which drugs should be monitored. Changes in the process were instituted in the year 2000. The first three medicines of a new class are now, by default, recommended to be considered for monitoring based on the premise that clinical trials alone produce inadequate safety data and therefore intensive monitoring is important in the early post-marketing period.

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