(1998; 262 pages)
The recommendations of the Conference of Experts on the Rational Use of Drugs held in Nairobi, Kenya in November 1985 are the basis of the WHO Revised Drug Strategy as endorsed by different subsequent resolutions of the World Health Assembly. Within the context of these resolutions, WHO is requested to prepare guidelines for a simple drug regulatory authority, and to support governments in setting up, or strengthening drug regulatory authorities.
In response to this, WHO has developed Guiding Principles for Small Drug Regulatory Authorities which have been endorsed by the WHO Expert Committees on Specifications for Pharmaceutical Preparations and on the Use of Essential Drugs. In addition, WHO has updated the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
To complement these administrative instruments, WHO has developed a Model System for Computer-Assisted Drug Registration which is now available after consultation and field testing in several countries. The acronym for the WHO model system is SIAMED. The main objective of the model system is to improve the efficiency of drug regulatory authorities enabling them to assure that marketing authorizations are consistent with their national drug policy. This is to be achieved through the provision of technical advice, a specifically designed, locally adaptable computer system, and assistance to make effective use of the system.