On the basis of the World Health Assembly’s recommendations, the World Health Organization (WHO) has prepared guidelines for a simple drug regulatory authority, and is supporting governments in setting up or strengthening drug regulatory authorities. To assist in this, WHO has developed a number of technical guidelines (see Annex 7) and updated the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
To complement these technical and administrative instruments, WHO has developed a Model System for Computer-Assisted Drug Registration (SIAMED), which is now available after consultation and field testing in several countries. This software programme was designed with the requirements described in this guide in mind.
The main objective of the model system is to improve the efficiency of drug regulatory authorities, enabling them to ensure that marketing authorizations are consistent with their national drug regulatory laws and regulations. This objective is to be achieved through the provision of technical advice, a cheap, specifically designed, locally adaptable computer system, and assistance to make effective use of it.
The development of the WHO model system has been undertaken with the realization that computerization alone is unable to replace proper regulations, qualified staff, and efficient work procedures and conditions. The provision of the software package and the present guide is therefore intended as a component of a broader national programme aimed at efficient drug regulation and registration, and encompassing legislation, regulations, human resources, and appropriate facilities.
Thus, the implementation of computer-assisted drug registration requires a feasibility study to define local specifications; the establishment of an appropriate organizational structure and reliable working procedures; the appointment of competent staff; allocation of resources; the adaptation of the software to meet local needs; and data entry and validation. Support, if required, can be provided by WHO for these activities.
This manual is based on experience gained from the implementation of the WHO Model System for Computer-Assisted Drug Registration software. Although this guide applies to any effort to computerize a drug registration system, when the text refers to “the system” or “this system” it is referring to the WHO software.