Post Authorization Safety Studies with Nancy Dreyer

Global approaches deposit approval safeties are changing across the world with much greater interest in watching the performance of new drugs and devices as they come to market. In order to bring new drug and medical device to the market in Europe, it is important to know the expectations of the regulators since the implementation of new legislation. Healthcare industries decided to review all the information available about the studies that have been proposed since the new legislations went into effect.

Pharmaceutical industries struggle to find out what kind of studies being done to satisfy requirements and also the process of working with the regulators and pharmacovigilance risk assessment committee (PRAC) in order to get their approval to proceed.

A hundred and eighty nine protocols were submitted to PRAC as:-

·        Most were longitudinal studies with a medium follow-up of three years.

·        Only four percent of the protocols formulated a hypothesis for testing and the rest mentioned descriptive analysis.

·        About third of the protocols were studies that were required as a condition of market authorization and other regulatory obligations.

·        Most protocols for orphan drugs were fulfilling the conditions for market authorization and most of the remaining protocols were submitted as commitment made in risk management plan.

·        It was surprising for the epidemiologist to see that the seventy percent of the   protocols have no comparator group focusing only on the product of interest.

·        Less than ten percent of the protocols were for the disease registries or cohort studies and not related to specific treatments.

In order to collect data, fifty eight percent of the post authorization safety study use primary data collection. In contrast, most drug utilization studies use secondary data or existing data.

Industries learn that the regulators are especially concerned about the feasibility of studies, study design and related methodology. So rather than expecting for designing the full proof study even through working with the best experts and the best available data, it’s very important to plan that there is need to bring best ideas to regulators and they can already have ideas that are needed to be incorporated.


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