Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 58

The ICH is not a regulatory agency or authority. It is however supported by regulatory authorities and regulatory authorities who were instrumental in establishing it as the organization which is looked to for investigative medicinal product standards. Industry trade organizations were partners in driving the establishment of the ICH. The members of those trade organizations committed scientific expertise and monetary support for the ICH so that the standards necessary to harmonize pharmaceutical drug development standards could be put in place. Those standards must then be translated into usable expectations which can be enforced as the must do or at a minimum held as the should do steps for pharmaceutical medicinal product development.

The ICH as a free standing nonaffiliated standard setting organization is in a position where it can develop a standard in an expedited manner compared to a regulatory authority. In particular the ICH, while its governance does include representatives from the regulatory authorities, does not need to go through lengthy and sometimes politically influenced reviews and challenges when developing a standard. The ICH follows a standard review process that reaches out to all parties, even the general public, but it is a process that is controlled and does not languish due to policy or political upheaval. The final work product must then be accepted and/or adopted by the regulatory authority but experience has already demonstrated that the regulatory authorities have found mechanisms to classify and categorize the ICH standards in a manner which lends relevance without having to translate them into law. The US FDA’s approach of translating ICH guidelines into Good Guidance Practices is an example.