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The African Medicines Agency (AMA) is a proposed specialised agency of the African Union (AU) intended to facilitate the harmonisation of medical regulation throughout the African Union. Following a similar model to that of the European Medicines Agency , it is intended to have a wide scope covering medicines , traditional medicine , and ...
The Treaty for the establishment of the African Medicines Agency is an international treaty, pending ratification and accession by at least 15 Member States of the African Union, to establish the African Medicines Agency (AMA) as a specialized agency of the African Union. The aim of the treaty, by establishing the AMA, is to address the issue ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
As of the Substance Act of 1965, The Medicines Control Council (MCC) and Directorate of Radiation Control (DRC) was formed. As of 2018, the South African Health Products Regulatory Authority (SAHPRA) was created to replace the MCC and DRC [4] [5]
The Medicines Control Council was set up in 1965, and it put all types of medicine under the same standards. It was replaced in 1998 by the South African Medicines and Medical Devices Regulatory Authority, which placed separate procedures for registering regular and alternative medicines, in order to regulate them better. [6]: 45 [109]
The matter arose when the Transvaal High Court was requested to review and set aside the President’s decision to bring the South African Medicines and Medical Devices Regulatory Authority Act 1998 into operation on 30 April 1999. The purpose of the Act was to govern the registration and control of medicines for human and animal use, and to ...
In one case, unauthorised semaglutide was recalled in South Africa in December, because of potential health risks, according to a public notice posted in January by the local medicines regulator ...
Herbal medicines in Africa are generally not adequately researched, and are weakly regulated. [5] There is a lack of the detailed documentation of the traditional knowledge, which is generally transferred orally. [6] Serious adverse effects can result from misidentification or misuse of healing plants. [1]