The European Directorate for the Quality of Medicines and HealthCare (EDQM) and the Chinese Pharmacopoeia Commission (ChP) today 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. In particular, the agreement entails the setting up of a Joint Executive Committee, which will be composed of experts from both parties and will establish working groups as well as explore ways to collaborate on topics of common interest.
Under the MOU, the Pharmacopoeias will promote co-operation and coordinate activities related to their common objective of ensuring the quality of medicines. They will also consider exchanging scientific information and expertise on developing quality standards, strengthening already well established working relationships as well as contributing to the common development of EDQM and ChP through training initiatives and exchange programmes.
Susanne Keitel, Director of the EDQM, expressed satisfaction with the agreement and added that: “In an ever more globalised pharmaceutical sector, co-operation among international pharmacopoeias on quality standards is essential to ensure that the protection of public health is based on the best scientific expertise available worldwide.”
The EDQM is the Directorate of the Council of Europe that ensures the basic human right of access to good quality medicines and healthcare 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).
Founded in 1950, the Pharmacopoeia Commission of China (ChPC) is tasked with drafting and revising the Chinese Pharmacopoeia. Its members are medical and pharmaceutical experts who remain in charge for a period of 5 years. This Chinese Pharmacopoeia provides the statutory requirements for pharmaceutical companies producing medicines for the Chinese market. Its latest edition came into effect on 1st December 2015.