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EDQM and ANVISA sign co-operation agreement to strengthen quality of medicines

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European Pharmacopoeia
International harmonisation
News
04 September 2017
Brasília, Brazil

The European Directorate for the Quality of Medicines and HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, today announced the signing of a Memorandum of Understanding (MOU) on their intention to strengthen relations and promote further co-operation in the field of medicines’ quality and science-based pharmacopoeial standards. This partnership will support exchanges of technical and scientific expertise, enhancing access to good quality medicines and health care, and streamline regulatory approaches in the control of medicines for the benefit of public health both within Europe and Brazil.

Under the MOU, the two institutions will look into adopting reciprocal standards, exchanging information on quality of medicines and sharing technical expertise on the establishment of monographs and test methods. The areas of co-operation will be broad and cover active pharmaceutical ingredients, as well as finished products, including chemically defined medicines, blood products, vaccines and biological medicines, and herbal products.

“Today’s announcement demonstrates the EDQM’s commitment to promote at global level public standards that are science-based,” said Susanne Keitel, Director of the EDQM. “This co-operation will lay the basis for ensuring the best quality for medicines and health care in both Europe and Brazil.”

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 mandatory standards for the quality control of medicines and their components; it is legally binding in 38 European Member States (including the European Union). Also, some 20 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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