Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Close this folder3. General basis for regulatory assessment
View the document3.1 Established properties
View the document3.2 Approaches to regulatory assessment and supervision
Open this folder and view contents4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the documentAnnex
View the documentAcknowledgements

3.1 Established properties

A basic principle is that the pharmacokinetics, pharmacodynamics, indications, safety and efficacy, and toxic or allergenic potential of a medicinal product should have been reasonably well established and documented in humans before its eligibility for use in self-medication can be assessed.

Where a new active pharmaceutical substance that has not been marketed as a prescription medicine is being considered for use in self-medication, the previous studies will have been conducted largely in animals. The clinical trials and investigations with such a substance should as much as possible reflect the self-medication situation, and subsequent collections of post-marketing data on long-term safety and efficacy may be necessary. These data must be sufficient to meet the criteria for self-medication.

When the release for self-medication of a medicinal product hitherto used only on prescription is being considered, it should first have been properly investigated as described above, and then employed for a number of years on a considerable scale in prescription medicine. The older the original product, however, the more likely it is that the original studies will prove to fall short of present-day investigational standards, and the more necessary it will be to rely on subsequent evidence, e.g. from incidental studies, adverse reaction reporting and general experience in the field.

Similarly, where the future status is being considered of a product already in use for a long time for self-medication, there is commonly a lack of formal prospective clinical studies matching present-day standards. Again it will often be necessary to draw conclusions from practical and circumstantial data, but if the medicinal product has been used on a large scale this may be possible.

Where the suitability of a fixed-combination product for use in self-medication is being considered, the basic principle will apply that the combination should be therapeutically rational, including only ingredients necessary for the treatment and containing no active ingredients that are superfluous to the treatment of the conditions in which efficacy for self-medication is to be claimed.

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