The European Medicines Agency works closely with organisations that establish standards for regulatory processes.
- International Organization for Standardization (ISO);
- International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
ICH and VICH
ICH and VICH are responsible for implementing ISO standards with respect to human and veterinary medicines. They bring together the regulatory authorities of Europe, Japan and the United States, and experts from the pharmaceutical industry in the three regions, to discuss scientific and technical aspects of product registration.
Their goal is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for the authorisation of medicines. They aim to lead:
- better use of human, animal and material resources;
- elimination of unnecessary delay in the global development and availability of new medicines, whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
The Agency also sits on the management board for the Medical Dictionary for Regulatory Activities (MedDRA), a specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for human medicines.
The Agency has also made a considerable contribution to the development of ISO standards falling within the remit of TC215: Health informatics, particularly 'individual case study reports in pharmacovigilance' and 'identification of medicinal products'.
Other international-standard organisations
The Agency also works closely with:
- European Directorate for the Quality of Medicines and Healthcare (EDQM), the organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use;
- European Committee for Standardization (CEN);
- Health Level Seven.
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