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
Open this folder and view contents3. General basis for regulatory assessment
Close this folder4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the document4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication
View the document4.2 Assessment for self-medication of medicinal products hitherto available only on prescription
View the document4.3 Assessment of existing self-medication products that have not previously been evaluated
View the document4.4 Assessment of new strengths, formulations, doses, indications or combinations
View the documentAnnex
View the documentAcknowledgements
 

4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication

The material should comprise pharmaceutical, pharmacological (preclinical and general pharmacological characterization of the compound), toxicological, clinical pharmacological (clinical trials) and long-term therapeutic data (efficacy and safety) obtained in appropriate experimental animals and humans. It will then need to be submitted to the regulatory authority for review. The clinical trials must address the specific issue of the use of the medicinal product in a representative self-medication population. Sufficient clinical experience of the use of a new active substance must be gained before marketing authorization of the product for self-medication can be granted.

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