Norms, standards and guidelines
Do you, or a family member, take a medicine? Have your children been immunized? The answer to both questions is very likely “yes”. In which case you may have, unknowingly, relied on norms and standards established by WHO for the medicines and vaccines.
The central importance of this work was recognized when WHO itself was established. Our Constitution requires WHO “to develop, establish and promote international standards with respect to biological and pharmaceutical products”. This has been done continuously for more than 60 years.
The backbone of this work are our Expert Committees; for biologicals and for pharmaceuticals. The international standards established by the Committees are public standards that facilitate and stimulate production and registration of medicines, are the basis for the WHO prequalification process, promote competition in generic markets, and contribute to the availability and affordability of quality medicines.
We also establish International Nonproprietary Names (INNs). An INN is a unique name for a new medicinal chemical or biological substance. WHO puts INNs in the public domain so that they can be used without restriction to identify pharmaceutical substances. INNs facilitate rational prescription and use of medicines, and help ensure their traceability.
Complex multinational supply chains increasingly are the reality for many essential medicines, meaning that better understanding and implementation of global standards will be critical.
Scientific advances in production and control of medicines will be translated into improved quality and more affordable products only if the standards setting programme keeps pace with the science. Standardization of certain product classes, such as biologicals, are rising up the agenda of many Member States.
Expectations will grow to reduce regulatory burden. New norms and standards will need to reflect these aspirations but not to the point where quality suffers. Standards setting expertise and resources likely will be insufficient in any one Member State to address all needs. Convergence of international norms and standards will be increasingly recognised as a key solution.
The aim of the Technology, Standards and Norms Team is to do all they can to uphold the excellence inherited from the past and to take us forward in an ever more complex and challenging world.
The normative and standards setting work of WHO in the area of medicines has served our Member States for over 60 years. Needs and expectations are growing.