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What expertise is available for medicines assessment and inspection?

FAQ
M

WHO staff responsible for assessments and inspections are generally recruited from regulatory agencies. They work with regulators from stringent regulatory authorities (SRA) (for example, SRA assessors attend the assessment sessions held in Copenhagen, adn SRA inspectors join WHO inspections as co-inspector) or to ensure that their levels of knowledge and expertise in medicines regulation and pharmaceutical science are maintained. They also work with regulators from low-income countries where the medicines will be used, to ensure that the process and results are understood and trusted by those countries.

Additionally, the assessment and inspection groups include rotational staff from low-income regulatory agencies. The rotational staff work with WHO prequalification colleagues for several months and then return to their agency. Upon their return home they share the knowledge and experience they have acquired with colleagues and also serve as an ambassador for WHO prequalification.