No DRA will be successful in implementing these guidelines if it does not have full and continuing government support, even when the government changes. The government must provide:
• Clear, firm, and equitable legislation that addresses all the relevant issues and carries appropriate sanctions for violations (see Annex 1);
• Support in the form of financial and other resources that are commensurate with the designated functions, particularly in relation to staffing and the resource needs for the GMP inspectorate and quality control laboratories;
• Advocacy in the political arena, and particularly a willingness to defend decisions and policies which may be unpopular with vested interests but which are to the benefit of public health;
• Support when legislated sanctions are imposed for violations of legislation.
The relevant political authority is usually the Minister for Health but may be a person or persons under a different title, depending on the country’s legislative system.
The appropriate level of financial support depends on what functions the government intends the DRA to undertake. If an authority is expected to review only well established drug products, not products containing new chemical or biological APIs, and to rely mainly on decisions made by DRAs in other countries, it would be reasonable for financing to be sufficient for only these functions, with further allowance for the evaluation of interchangeability and of locally developed and manufactured products. More extensive responsibilities would require additional resources. A system of fees for evaluation of applications and subsequent retention fees to maintain the marketing authorization is one means of recovering costs and is further discussed below.
The budget should be subject to adjustments according to the resources required for the DRA’s functions as they evolve.
A number of decisions of principle must be made by government at a very early stage (see particularly Part II “Rational selection of drug products”, and Part IV “Initial decisions on options for premarket evaluation”). These decisions should be issued in writing, and should not be changed so often that a coherent and consistent approach becomes impossible.