It is impossible to evaluate these three criteria in an isolated fashion since these are interrelated. The product quality is assessed not just in absolute terms but taking into account its effect on safety and efficacy and considering the manufacturing standards in place. The assessment of safety and efficacy must include a rigorous evaluation of the risk versus benefit balance since the acceptability of the unintended side effects will be different for life-saving drugs than for those used to treat minor ailments (Cartwright AC, Matthews BR, 1994, p 422).
However, this is dependent on the data provided by the manufacturer that summarizes innovative aspects of the drug based on the chemistry of the drug, animal toxicology, mechanism of action, and initial clinical trials. These would identify the special approaches to drug development that would be considered during licensing. It is also required to summarise the characteristics of the disease or diseases for which the drug is to be used. Healthcare needs and benefits are to be enumerated. The data about the drug must be collected from countries outside the region in which the licensing is applied and the summary of the data about drugs marketed by the competitors are to be recorded (Food and Drug Administration).
Multidisciplinary teams of assessors work on the product license application and can consult external experts on a formal or informal basis when needed. All new products are assessed and then the report is submitted formally to the Committee on Safety of Medicines, the statutory committee responsible for advising ministers on regulatory issues for advice. It can be argued that since the work of regulating medicines funded by user fees on each product license, not only the licensing investigation but also inspection of manufacturing facilities and authorization of clinical trials may be affected because the funding is done by the licensee.
Naturally, this may prevent regulators from taking difficult decisions. The basic goal should be to ensure the scientific independence of the regulatory system (Eisenberg, R. S., 1996).
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