Drug legislation forms the basis of drug regulation. It must be comprehensive and enforceable if it is to be effective. Countries should therefore update their drug legislation if it is obsolete or inadequate. Important determining factors of the effectiveness of drug legislation include the extent to which the legislative framework is in accord with national policies, the degree of regulation which the government considers desirable and practicable to exercise, and the situation in its country’s pharmaceutical sector.

In particular, drug legislation should be sufficiently comprehensive and flexible to meet the objectives of drug regulation. Flexibility can be achieved by adopting a basic drug law and giving the executive branch of the government the authority to formulate the detailed requirements of drug regulations. In general, drug legislation must:

• define the areas and activities to be regulated;

• state the roles, responsibilities, rights and functions of all parties involved with drug regulation, including those of the regulators and regulates;

• create the administrative bodies necessary for implementation of drug regulation, and define their structural and functional relationships;

• set the qualifications and standards required for those handling drugs;

• create mechanisms to ensure that all responsible parties are licensed and inspected to ensure compliance with the provisions of drug legislation, as well as with the standards and specifications set for persons, premises and practices;

• define the norms, standards and specifications necessary for ensuring the safety, efficacy and quality of drug products, as well as the appropriateness and accuracy of drug information;

• state the terms and conditions under which licences to import, manufacture, distribute, sell, supply and promote drugs will be suspended, revoked or cancelled;

• establish the administrative measures and legal sanctions that will apply when provisions of drug legislation are violated.