ICH Guidelines
From The Embassy of Good Science
ResourcesGuidelines
ICH Guidelines
What is this about?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.
Why is this important?
ICH’s mission has been embodied in its Articles of Association as follows:
- To make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations;
- To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products;
- To contribute to the protection of public health in the interest of patients from an international perspective;
- To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data;
- To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;
- To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices;
- To encourage the adequate implementation and integration of common standards through the dissemination of, the communication of information about and coordination of training on, harmonised guidelines and their use;
- And to develop policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA) whilst ensuring the scientific and technical maintenance, development and dissemination of MedDRA as a standardised dictionary which facilitates the sharing of regulatory information internationally for medicinal products used by humans.
For whom is this important?
medical researchersPharma IndustryClinical researchersResearchersAdministratorsLaboratory researchersPhysicianspolicy-makers in science
