Transparency means (1) defining policies and procedures in print and publishing the printed documentation, and (2) giving reasons for decisions to the party concerned. DRAs should adopt a policy of transparency because it is the simplest and most efficient way of conducting business. While the circulation of some documentation may need to be restricted, for example during policy development, the majority of finalized written documents (and particularly those concerning policy and administration) should be made available to DRA staff, the pharmaceutical industry, the parliament and the general public. DRAs with limited resources may achieve cost savings by posting their guidelines on the Internet. Transparency has these advantages:
• Applicants and the DRA do not spend time trying to clarify each other’s policies and attitudes.
• Staff within the DRA do not spend time determining what their own agency’s policies are (“reinventing the wheel”).
• Communication at all levels is facilitated if each party understands the other’s starting point for discussions.
• Terminology is defined in policy documents so that the parties use the same terms to mean the same thing.
Transparency also means giving reasons for decisions. For example, letters rejecting applications should include reasons for the decision.