Drug Regulation Structure
Analysis of drug legislation and identification of weaknesses
• What is the mission of drug regulation? Is this mission formally written down?
• Is drug legislation comprehensive?
• Are the areas to be regulated defined?
• Are functions, responsibilities and powers of all the relevant parties defined?
• Are drug regulations, norms, standards and procedures adequate?
• Are there provisions for penal sanctions and administrative measures?
• Does the legislation impose on the regulatory authority any duty to provide information to the public?
Analysis of organizational structure and identification of weaknesses
• Is the regulatory government body federal, state or local?
• Is it a quasi-governmental body?
• Does the drug regulation structure provide independence in decision-making?
• Does the structure provide autonomy, both financially and in terms of recruiting staff?
• Is the distribution of responsibilities, duties and powers in accordance with written terms of reference and drug legislation?
• Are structural and functional linkages between various bodies involved in drug regulation clearly defined?
• Do staff have job descriptions?
• Is the private sector involved in drug regulation activities? If so, is there a legal basis for this? Are the relevant parties accountable? Are they required to submit reports?
• Are planning, monitoring, evaluation and reporting mechanisms in place?
• What are the main constraints with regard to organization and structure? What are the reasons for them?
Assessment of human resources availability and quality, and identification of constraints to implementing drug regulation
• Is the number of staff adequate?
• Do staff have the required qualifications and skills to perform their jobs adequately?
• Do staff believe in the objective of drug regulation?
• Are staff motivated to do their work?
• Is there a system for human resources development?
• Are staff salaries comparable to those paid to similarly qualified individuals in the private sector?
• What are the main constraints in terms of human resources availability? What are the reasons for them?
Assessment of financing mechanisms and identification of constraints
• How is drug regulation financed?
• Is there a specific government budget for drug regulation?
• Is financial sustainability a problem?
• Is there legal provision for collection of fees?
• Are fees collected?
• Is the regulatory agency allowed to use them?
• What are the main financial constraints?
Availability of other resources
• Are resources - such as means of transport, laboratory equipment and apparatus - that are essential for regulation activities readily available? Do they function properly? Is there a maintenance system?
• Is an adequate number of rooms available?
Availability, clarity and transparency of procedures and guidelines
• Are all procedures, guidelines and guides used in drug regulation written down?
• Are they published and distributed to all interested parties?
• Are decisions made by the agency published and distributed to all interested parties? Are they sent only on request?