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
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Close this folderRegulatory challenges: health sector reform and drug regulatory capacity
View the documentStrengthening regulatory capacity during reform
View the documentThe creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation
View the documentThe South African experience
View the documentDrug registration and importation control in Tunisia
View the documentHealth reform and drug regulation in Venezuela
View the documentEconomic regulation of pharmaceuticals in Brazil
View the documentRecommendations
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
 

The South African experience

Ms Malebona Precious Matsoso, South Africa

One of the main aims of health sector reform in South Africa is to integrate a very fragmented health service and to develop a national drug policy and essential drugs programme, neither of which existed before 1994. The Medicines Control Council is moving towards performancebased units. It will base its work on an electronic regulatory system and is planning to acquire more in-house regulators. Improvements in the legislative framework are planned in relation to complementary medicine and harmonization. South Africa’s regulatory changes on parallel importation and generic substitution have already caused controversy. Other recent achievements of the agency include audits for clinical trials, setting-up of a law enforcement unit, GMP inspections of foreign manufacturers and safety monitoring of antiretrovirals.

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