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The proposed African Medicines Agency (AMA) is a continuation of existing medical regulatory harmonisation efforts in the continent. [3] [4] Across Africa it is estimated that only 3% of required drugs are produced, [5] with medicines not readily available during health emergencies. [6]
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 ...
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 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 ...
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 ...
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]
In February 1998, the South African Pharmaceutical Manufactures Association and forty Multinational Corporations (MNC) brought a suit against the government of South Africa for its passage of the Medicines and Related Substances Control Amendment Act No. 90 of 1997, arguing that it violated the Agreement on Trade-Related Aspects of Intellectual Property Rights.
The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new ...