Quality assurance and safety of medicines: Main challenges and strategic direction
1. Nomenclature
Every new active pharmaceutical ingredient needs an International Nonproprietary Name (INN, generic name) in six languages. These INNs are assigned by WHO following a standardized and transparent consultation procedure. A service fee is charged. Other classifications are Anatomical Therapeutic Chemical (ATC) Classification codes, Daily Defined Doses (DDD) used for drug use research, and the WHO Drug Dictionary for adverse drug reactions.
QSM will continue this very technical work, which is both essential and globally unique.
2. Quality norms and standards
Many regulatory agencies use global standards issued by WHO (e.g Good Manufacturing Practice, the International Pharmacopoeia, chemical reference standards, bioequivalence guidelines and classification of narcotics). A mature system of global consultation procedures and expert committees is maintained for continuously updating and expanding such standards (e.g. quality standards for prequalification of new ARVs and fixed-dose combinations).
QSM will continue to develop and disseminate global policies, norms and standards.
3. Drug safety and regulatory information exchange.
Most health workers badly need unbiased medicine information. Adverse reactions are a common cause of illness and death. WHO coordinates the International Programme for Drug Monitoring with centers in 75 countries and a global database of 3.5m reports in Uppsala. Information is disseminated to regulatory authorities through periodicals, newsletters, drug alerts and a UN consolidated list of regulatory restrictions and withdrawals.
QSM will continue to disseminate information on regulatory decisions and safety alerts to regulatory bodies. It will expand drug safety monitoring programmes in developing countries, especially for new HIV, TB and malaria medicines.
4. Prequalification of priority medicines
On behalf of the UN system WHO performs voluntary assessments of quality, safety and efficacy of priority medicines for HIV/AIDS, TB and malaria, following a a strict procedure and standards established by several Expert Committees. The list of "prequalified medicines" is used by many other organizations (GFATM, World Bank, UNICEF and MSF) and Member States to guide procurement and funding decisions. There is much demand to increase its services.
QSM has developed a business plan to forecast demand and estimate required resources. More medicines for TB, malaria and reproductive health will be included, as well as drug quality control laboratories. It will streamline and harmonize other quality assessment procedures within WHO (e.g. disease programmes) and the UN (e.g. UNICEF and UNFPA).
5. International and regional harmonization of medicine regulation
Most Member States are involved in international and regional harmonization of medicine regulation; WHO's global standards often serve as a starting point. Many regulatory bodies also need technical advice. WHO's biennial International Conference for Drug Regulatory Agencies (ICDRA), the only truly global and fully independent forum for regulatory agencies, is essential in promoting global consistency in pharmaceutical norms and standards.
QSM will continue to organize biennial ICDRA conferences and will represent the global perspective and the interests of developing countries in the International Conference on Harmonization (ICH) and its technical working groups. Together with TCM and regional offices QSM will continue to support regional harmonization efforts and national agencies.