The quality of substances for pharmaceutical use must be assessed on the basis of continuously updated standards regarding the scientific and technological process, published in the national pharmacopoeia to guarantee their safety of use and efficacy.
For the European Union countries, the pharmacopoeia is made up of texts in force by the European Pharmacopoeia and by any national pharmacopoeias such as, in Italy, the Official Pharmacopoeia and its Secretariat.
The Secretariat is a technical structure that coordinates the activities related to the revision and elaboration of the Official Pharmacopoeia and the transposition of the European Pharmacopoeia. It also constitutes the national interface with the European Pharmacopoeia and with the European Directorate for the Quality of Medicinal Products (EDQM) for all the activities of the European Pharmacopoeia Commission and its expert groups.
