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EDQM and ANVISA sign Memorandum of Understanding on use of CEPs in Brazil

Certification of suitability (CEP)
11 October 2017
Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal products.

The Memorandum of Understanding signed between the EDQM and ANVISA focuses in particular on building a system of trust between the two organisations, which will underpin all future cooperation and will be further specified in an overall roadmap to a phased approach on the use of CEPs by ANVISA. It will lay the basis for streamlining resources and contribute to a more harmonised approach in regulatory activities on Active Pharmaceutical Ingredients (API).

Confidence building activities will be essential for ANVISA to incorporate CEPs into its evaluation of MAAs. Both partners considered the specific circumstances in which sharing of information held by one partner will assist the other in carrying out its regulatory functions. 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-organise technical workshops, on-site visits, programmes related to the European Pharmacopoeia, laboratory activities and joint comparison exercises on the suitability of CEPs.

The EDQM, a Directorate of the Council of Europe, contributes to ensuring the basic human right of access to good quality medicines and health care in Europe. Its European Pharmacopoeia defines standards for the quality of medicines; it is legally binding in 38 European Member States (including the European Union). Currently 27 European and non-European countries, the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA) are observers to the European Pharmacopoeia Commission and participate in its scientific work.

ANVISA is the Brazilian Health Surveillance Agency, ruled by a Collegiate Board of Directors composed of five members. ANVISA’s primary goal is to protect and promote public health.

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