EDQM, Anvisa Sign MoU for Information Sharing

The European Directorate for the Quality of Medicines & HealthCare (EDQM), a body responsible for the European Pharmacopoeia, and Agência Nacional de Vigilância Sanitária (Anvisa), the national health surveillance agency of Brazil, have signed a memorandum of understanding that provides the foundation for Anvisa to consider the use of certificates of suitability (CEPs) to the monographs of the European Pharmacopoeia for their evaluation of marketing authorization applications for medicinal products. The memorandum is intended to lay the basis for streamlining resources and contribute to a more harmonized approach in regulatory activities on active pharmaceutical ingredients.

Information-sharing will be an important component in carrying out regulatory functions, noted EDQM in a statement. In particular, the memorandum will see the EDQM informing Anvisa on all actions taken in relation to CEPs or applications for CEPs, including reasons for GMP non-compliance, whereas EDQM inspection and quality assessment reports will be made available upon request by Anvisa. The two partners also agreed to exchange information on their respective review practices and co-organize technical workshops, on-site visits, programs related to the European Pharmacopoeia, laboratory activities, and joint comparison exercises on the suitability of CEPs.

Source: EDQM


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