How to read and use Pharmacopoeias

Drug registration is subject to regulatory constraints specific to the region in which the drug is registered. In fact, obtaining a marketing authorization in a given country or region is conditional, among other things, on the drug's compliance with the regulatory standards in force there. These standards are generally compiled in Pharmacopoeias and in guidelines issued by regulatory authorities. The globalization of the market is prompting authorities to embark on a process of harmonizing these standards. The most representative example is the International Harmonization Council (ICH), which brings together regulatory authorities and professionals from five major regions: Europe, the United States, Japan, Canada and Switzerland. However, while the ICH guidelines resulting from this process provide a degree of convergence on crucial points, specificities persist, particularly within regional...