The norms and standards for pharmaceuticals developed by WHO are prepared through a vast global consultative process involving WHO Member States, national regulatory authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, specialists from industry, national institutions, nongovernmental organizations, and so on. These draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, are thereafter adopted as international standards.
This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.
The guidelines under development/for comment are under working documents in public consultation.
