MEDICINES REGULATORY SUPPORT http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/

Medicines regulatory support

Effective medicines regulation promotes and protects public health by ensuring that:

• medicines are of the required quality, safety and efficacy;
• medicines are appropriately manufactured, stored, distributed and dispensed;
• illegal manufacturing and trade are detected and adequately sanctioned;
• health professionals and patients have the necessary information to enable them to use medicines rationally;
• promotion and adverting is fair, balanced and aimed at rational drug use;
• access to medicines is not hindered by unjustified regulatory work.

National governments are responsible for establishing strong national medicines regulatory authorities (MRAs) with clear mission, solid legal basis, realistic objectives, appropriate organizational structure, adequate number of qualified staff, sustainable financing, access to up-to-date evidence based technical literature, equipment and information, capacity to exert effective market control. MRAs must be accountable to both the government and the public and their decision-making processes should be transparent. Monitoring and evaluation mechanisms should be built into the regulatory system to assess attainment of established objectives.
The role of WHO in the area of medicines regulatory support is two-fold. One aspect relates to the development of internationally recognized norms, standards and guidelines. The second aspect relates to providing guidance, technical assistance and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs.