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.
Regulatory support activities
The activities of WHO in the area of medicines regulatory support focus on supporting the work of national MRAs. This materializes as:
- Model web site for medicines regulatory authorities
- Model system for computer-assisted medicines registration (SIAMED)
- Certification scheme on the quality of pharmaceutical products moving in international commerce
- International Conference of Drug Regulatory Authorities
- International Cooperation and Harmonization
The successful implementation of our activities is based on fruitful collaboration with other Clusters/Departments of WHO and the Regional Offices, other UN agencies, national Medicines Regulatory Authorities, international development agencies and institutions, Non-Governmental Organization's, national and international pharmaceutical manufacturers associations, health professionals, consumers, and experts.