Ms Fadwa Murad, Syria
Mr Raoul Massing Bias, Cameroon
Syria and Cameroon are two countries where the WHO Model System for Computer-assisted Drug Registration has been successfully implemented.
The main objective of the WHO Model System is to improve the efficiency of drug regulatory authorities by enabling them to ensure that marketing authorizations are consistent with their national drug laws and regulations. This objective is achieved through the provision of a cheap, specifically designed, locally adaptable computer system, technical advice and assistance.
Benefits observed after computerizing drug registration
The drug registration process and related activities benefit from the adoption of the WHO Model System. In particular by allowing:
• More time for professional work.
• Fewer inaccuracies, oversights, and mistakes.
• Improved communication within the regulatory authority.
• Increased efficiency.
• Improved quality of work.
A stepped process enables the effective transition from a manual drug registration system to a computer-assisted system as follows:
In our countries, no previous computerized system existed, therefore computerization has obliged us to look into our working procedures and to adapt them.
• Funding sources had to be targetted.
• Preparatory work was carried out to decide which data to record into the computer system and check whether our files contained accurate information.
• In many cases files were incomplete and companies were asked to re-submit information.
• Data for computerization was evaluated by completing a data entry form, deciding on a drug classification system, and preparing codes and abbreviations for standardized data entry.
• A strategy was elaborated to enter the existing information in the manual system and at the same time take care of the new incoming applications: we opted for entering the backlog gradually while accepting new applications.
• Staff were trained to the use of the new system. In doing this we had to deal with the perception that using a computer challenged staff status. Information that needs to be stored in a computerized drug registration system is of a technical nature and its handling requires technical judgement.
Problems and lessons learnt
Computerizing drug registration is a major undertaking! We started thinking that one staff acting as focal point could take care of this activity in a relatively short time. However, we soon realized that we needed the support of all staff, and particularly from senior management.
The areas which need most attention were ensuring that everyone is aware of the reasons for introducing the computer system and of what is expected from the new situation; ensuring that attitudes toward the use of computers are appropriate; and creating skills to match the new tasks or new ways to perform routine tasks.