Experience in developed countries has shown that development of regulatory capacity occurs in phases, over a long period of time. Factors such as the level of development of the pharmaceutical sector and the availability of trained human resources, infrastructure and financial resources, influence the types of regulatory functions that can be carried out, as well as the size and sophistication of the regulatory agency.

Developing countries that are totally dependent on imported drugs and which have limited qualified human and other resources will thus need to start with limited priority activities, expanding these gradually as their pharmaceutical sectors develop and resources become available. Priority-setting is particularly important in circumstances where the need for drug regulation is not acknowledged by decision-makers and political support accordingly not as strong as is desirable. In such situations, any attempt to introduce all regulatory measures and a complete regulatory process all at once will lead to failure and frustration.

In setting priorities, a regulatory agency must first decide what exactly it wants to regulate, what activities it wants regulates to perform, and how it can ensure they perform them. This requires the formation of a policy group on drug regulation, to bring together persons from different fields and disciplines so that drug regulation can be dealt with in an integrated manner. The issues to be discussed will include: the regulatory processes, strategies, and organization and management of drug regulation. Once the scope of operations has been defined, the next step will be to create the necessary procedures and practices for making regulatory decisions. Along with these, the agency must also consider monitoring and enforcement procedures. Annex 3 presents different levels of drug regulatory activity, corresponding to the financial and human resources available to a country, and the level of development of its pharmaceutical industry.