The South African Health Products Regulatory Authority (SAHPRA) is updating certain active pharmaceutical ingredient (API) names used in South Africa to bring them into line with international nomenclature. Further name changes are also taking place – to improve consistency within South African approved terminology and remove non-harmonised, duplicate and out-of-date names.

The objective of harmonisation is to maintain clarity and consistency in API naming in order to support quality use of medicines. Consistency in naming supports the quality use of medicines by:

  • minimising the risk of prescribing, dispensing and self-selection errors;
  • enhancing consumer safety (through easier international information sharing); and
  • avoiding consumer confusion and the potentially inappropriate use of medicines.

The use of non-harmonised, out-of-date or multiple API names can create significant problems for the pharmaceutical industry, consumers and healthcare professionals. South African consumers who travel internationally, healthcare professionals who have trained overseas or the public trying to access medicine information online may be unfamiliar with international medicine ingredient names and increase the risk of prescribing, dispensing and self-selection errors.

The WHO International Non-Proprietary Names (INN) are the global reference for medicine ingredient names. The list of WHO-approved INNs is updated twice a year. These updates include changes to the spelling or structure of existing ingredient names and the creation of new INN.

The process of amendment described in this communication has been undertaken by a number of other countries over the years, including the United Kingdom in 2003, New Zealand in 2008 and Australia in 2016.

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