The scope, nature and practices of drug regulation, including the priorities, standards and norms, the enforcement strategies, resources available and the rigour of enforcement, vary from country to country. However, the goals are generally the same: promotion and protection of public health by ensuring the safety, efficacy and quality of drugs, and the appropriateness and accuracy of product information. Drug regulation encompasses several processes, as shown in Figure 1.

Figure 1. Dimensions of drug regulation

There is no benchmark or standard for drug regulation. What is effective varies from country to country. But an effective drug regulatory body is one that demonstrates results in accordance with the objectives and targets set for it. This in turn requires that it has a clear written mission and goals.

A drug regulatory body should:

• base its decisions on scientific evidence and facts;
• provide efficient and timely services;
• have the capacity to develop practicable regulatory and enforcement strategies (i.e. is dynamic);
• apply sound management principles;
• reach its objectives cost-effectively;
• be accountable;
• operate a safeguard against corruption and conflict of interest.

The process of drug regulation should be transparent.

Countries desiring to make their drug regulation effective need to take at least the measures described below.