ICH-GCP & FDA Regulations Differences. John D. Burke Director, Human Subjects Protection Program University Of Louisville April 21, 2009. International Conference on Harmonisation (ICH).
John D. Burke
Director, Human Subjects Protection Program
University Of Louisville
April 21, 2009
The International Conference on Harmonisation (ICH) ……. for Registration of Pharmaceuticals for Human Use ….. brings together the regulatory authorities of Europe, Japan, and the United States and experts
from the pharmaceutical industry …. to discuss scientific and technical aspects of product (development) registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration (development) in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
The objective of such harmonisation is a more economical use of human, animal and material resources, and the 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.
ICH requires Investigators (or designees) to:
ICH requires Sponsors to provide insurance or indemnify the investigator against claims arising from the trial.
If the University of Louisville Human Subjects Protection Program were to become ICH-GCP compliant, the UofL IRB would provide the following statement to investigators who conduct Clinical Trials for sponsors intending to submit study results to European Union, Japanese or United States pharmaceutical manufacturers for drug approval.
harmonisation vs. harmonization