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This chapter discusses standards, an elusive term and concept. For the African pharmaceutical sector especially, the term is used by the manufacturing sector, regulators, technical experts, procurement agencies, health system actors and policy makers to mean different things. There is a dearth of systematic studies that address what standards are, their classification and the logic behind their set-up and operation, and this has contributed to a huge asymmetry in understanding. The socio-economic, technical and political issues and how they have an impact on local production and industry development, including their effects on access to markets, have also not been systematically explored.

Pharmaceutical Standards in Africa: The Road to Improvement and Their Role in Technological Capability Upgrading