Lists of Agreements concluded by the EDQM, Council of Europe with other International Intergovernmental Organisations or Public International Institutions
This list is subject to modifications, and is provided for information purposes only.
The EDQM has signed a confidentiality agreement with the European Medicines Agency (EMA) and the EU Commission (Directorate General Health) on the exchange of non-public information on medicinal products.
The Agreement will facilitate transfer of regulatory information within the context of current legislation on data protection and confidential information. It is part of the efforts of the EDQM, the EU Commission and the EMA to make the best use of resources for ensuring the quality of medicines and the protection of public health in Europe.
The 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 EDQM and ANVISA, 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.
The EDQM and the Chinese Pharmacopoeia Commission (ChP) announced the signing of a new Memorandum of Understanding (MOU) for the next four years. This new agreement is aimed at promoting co-operation on the safety and quality of medicines in China and Europe.
The EDQM and MHLW (Japan) signed a Memorandum of Co-operation which defines concrete measures for strengthening collaboration between the European and Japanese Pharmacopoeias (Ph. Eur. and JP, respectively). In particular, the memorandum will allow sharing of information generated by GMP inspections of active pharmaceutical ingredient (API) manufacturing sites of interest to both Europe and Japan.
The EDQM and Health Products & Food Branch (HBFB) of the Department of Health (Canada) signed a Memorandum of Understanding for the exchange of information generated by the EDQM through its certification procedure and by HBFB during the course of applicable product assessments.
Bilateral confidentiality agreements were also signed between the EDQM and the health authorities of Armenia, Israel and Japan to allow the exchange of confidential information on the quality of active substances in the context of the Certification Procedure.
An agreement was signed between the EDQM and the European Medicines Verification Organisation (EMVO), which is comprised of various European supply-chain operators. In this context, the EDQM will verify that the system is designed, managed and operated in accordance with the standards in the delegated regulation on the Unique Identifier (EU 2016/161) , which implements the EU Falsified Medicine Directive (Directive 2011/62/EU). This initiative will help establish member states in their role as supervisors of traceability systems.
The EDQM and the Medicines Control Council of the Republic of South Africa signed a Confidentiality agreement to allow the exchange of confidential information related to the quality and manufacture of substances for pharmaceutical use and in particular APIs, including non-public and proprietary information.
A confidentiality agreement was signed by the EDQM and the Taiwan Food and Drug Administration (TFDA) in the context of the Certification Procedure.
The EDQM and the Federal Service on Surveillance in Healthcare & Social Development (Russia) signed a Confidentiality agreement to allow the exchange of confidential information related to the quality and manufacture of substances for pharmaceutical use and in particular APIs, including non-public and proprietary information.
Other MoU/agreements signed:
Health Science Authority (HAS) Singapore
State Administration of Ukraine on Medicinal Products (Ukraine)