Регуляторные исследования и экспертиза лекарственных средств (Jun 2023)
The International Pharmacopoeia: Focus, Processes, Response to COVID-19 and Collaboration with other Pharmacopoeias
Abstract
The World Health Organisation develops and promotes international standards for pharmaceutical products, in support of efforts to increase access to quality-assured medicines for all, and to safeguard patients from substandard and falsified medicines. The International Pharmacopoeia is a key output of this work. Its focus, processes to establish texts for inclusion or revision, response to COVID-19 and the collaboration with other Pharmacopoeias shall be discussed in this review. Pharmacopoeias provide public standards (written norms as well as physical reference standards), which ensure the quality of medicines by defining the attributes that are essential to their safety and efficacy. They consist of analytical methods to test for the identity, purity and content of pharmaceutical products, together with acceptance criteria to evaluate test results, and information about storage, labelling and production. Pharmacopoeias greatly facilitate the development of multi-source medicines (generics) by defining minimum quality standards that a group of medicines must meet in order to be considered of commensurate safety, quality and effectiveness as the originator product(s). The added value of The International Pharmacopoeia lies in its focus on monographs of particular relevance to lowand middle-income countries which may not have sufficient resources to develop national pharmacopoeias. In a globalised world, where medicines and health products are frequently sourced from several countries with differing regulatory standards and requirements, and when the response to Public Health Emergencies of International Concern, like the COVID-19 pandemic, necessitates swift and equitable access to urgently needed quality-assured therapeutics, such a resource is indispensable.
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