The introduction of a drug to the market is controlled by different procedures, designated by such terms as “registration” or “licensing” in various countries. Uniform designations are given below to avoid possible confusion. The procedures thus described may be gradually evolved through discrete phases.
A notification procedure is the least resource-intensive way of obtaining information on drugs offered for sale in a country. The amount of information requested for notification may vary. It may be initially restricted to the name of the drug and of the manufacturer, and may then be expanded to include the nonproprietary names for active substances, the composition, including inactive ingredients, and the pharmacological classification.
An authorization procedure can be developed in which either all drugs or specified ones only require an authorization before they are marketed in the country. This procedure may vary in its stringency but it almost always incorporates the element of inspection of the manufacturer and the verification of product quality by analysis.
A registration procedure comprises the evaluation of data intended to prove the safety and efficacy of the drug and to determine the indications for its use. The registration may include an assessment both of the drug and of the manufacturing procedures. Pharmaceutical aspects of drug evaluation for registration are described in Annex 5 of the twenty-fifth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (2). Some pertinent safety and efficacy aspects are reviewed in the report of a WHO Scientific Group on Guidelines for Evaluation of Drugs for Use in Man (9).
For products which have been used extensively and for which sufficient experience exists to demonstrate the safety of the active ingredient in similar types of preparation, the administrative requirements may be reduced to a declaration of manufacturing data and pharmaceutical quality specifications.