Regulatory Harmonization

Regulatory Harmonization is beneficial for both the government that has a role in monitoring pharmaceutical products and pharmaceutical industry and consumer protection as previously mentioned in the drug quality articles that various ICH guidelines were first published in 2000 by academic working group consisting of experts from the government and private sector with an intention to reduce the gap between regulation and guideline to report and evaluate safety information, quality and efficacy of new drugs. This difference leads to an overlapping experimental process that is both time consuming and costly. As a result, this process delays patient access to new drugs that are more effective.

ICH process is to improve the regulatory process to be more effective, prevent the overlapping works during clinical research, and limit the animal testing to the minimum level while maintaining drug safety and efficacy. Hence, the process effectively makes use of resources. Moreover, the regulatory harmonization helps patients to gain access to high-quality drugs faster. The ICH standard is also recognized that it will give health benefits to the world population in an international standard.