International Council for Harmonisation (ICH)
Merriam-Webster dictionary defines the word Harmony as "to bring into consonance or accord". Harmonisation helps different departments in local authorities share the same vision, work together and optimize the use of resources. The concept of harmonisation is highly essential in the pharmaceutical industry to ensure safe and effective development, manufacture, storage, and registration of drugs whilst meeting high standards.
In this article, I help you understand the need for and the role played by the International Council for Harmonisation in the Pharmaceutical industry.
About ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. It works side-by-side with the regulators and the pharmaceutical industries to develop guidelines for the safe and effective manufacture of drugs. ICH's mission is to ensure harmonisation worldwide by publishing guidelines which is successfully implemented by the regulators.
ICH's mission statements as stated on its website are below:
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 that 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 a 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 standardized dictionary that facilitates the sharing of regulatory information internationally for medicinal products used by humans.
History
Organization Structure
Source: ICH.org
Auditors
The responsibility of the Auditors is to audit the financial statements of the Association upon conclusion of each Fiscal Year. They should ensure that the accounting of the Association complies with Swiss law and generally