Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Close this folderHarmonization II
View the documentRegional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
View the documentHarmonization in the Americas
View the documentCentralized drug registration system in the Gulf Region
View the documentRecommendations
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Centralized drug registration system in the Gulf Region

Dr Laila A. Rahman, Bahrain

The Gulf Cooperation Council (GCC) represents Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, which have a shared culture, history and environment. A unified drug purchasing scheme was started in the 1970s by a group of pharmacists, to reduce drug costs and allow procurement of large quantities of drugs. In order to make purchasing more rational, a unified system of registration was also needed. There were complaints from patients about not receiving medications on time and from manufacturers about problems in bureaucratic systems in some countries. The GCC Drug Regulatory Committee was thus established in 1997 to centralize registration. It consists of two representative members from each country and appoints advisers from the academic area when necessary. Meetings are held at least four times a year.

Work has been done in three stages. The first stage was a two-year period, during which all pharmaceutical companies and their products, and research-based companies, in the countries were registered. In the second stage, the programme was evaluated and generic drugs from local manufacturers were registered. The third stage will begin soon and will cover all complementary products (e.g. cosmetics, health food, herbs, etc.).

Current problems arise from the fact that some multinational companies do not accept the concept. In addition, the Ministers of Health in most GCC countries have expressed their doubts about the need for expertise in registration, and some are afraid of losing sovereignty to the centralized authority. On the positive side, coordination among the six countries has led to the development of human resources and a good inspection team, more international collaboration, and mutual understanding. WHO has been very supportive of this system. In the future, more time will be needed for follow-up and postmarketing activities in the individual countries.

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