What is a primary purpose of the International Council for Harmonisation (ICH)?

What is a primary purpose of the International Council for Harmonisation (ICH)?

• A. Require FDA registration of worldwide clinical trials
• B. Minimize the need for redundant research
• C. Develop mandatory worldwide regulations for drug development
• D. Require publication of negative trial results

Answer: (B)

The primary purpose of the International Council for Harmonisation (ICH) is to minimize the need for redundant research. This is achieved by harmonizing the regulatory requirements for pharmaceuticals across different countries and regions. By establishing a unified set of guidelines and standards for drug development and approval processes, ICH aims to streamline research efforts, reduce duplication of studies, and improve the efficiency of clinical trials. This harmonization helps ensure that the data collected is valid and accepted across various regulatory jurisdictions, ultimately speeding up the availability of medications to patients while maintaining safety and efficacy standards. This goal of minimizing redundant research also addresses the ethical considerations in clinical trials, ensuring that fewer resources are spent on unnecessary duplication of studies that do not contribute additional significant knowledge. As a result, the ICH facilitates a more effective and responsible approach to drug development on a global scale.

The primary purpose of the International Council for Harmonisation (ICH) is to minimize the need for redundant research. This is achieved by harmonizing the regulatory requirements for pharmaceuticals across different countries and regions. By establishing a unified set of guidelines and standards for drug development and approval processes, ICH aims to streamline research efforts, reduce duplication of studies, and improve the efficiency of clinical trials. This harmonization helps ensure that the data collected is valid and accepted across various regulatory jurisdictions, ultimately speeding up the availability of medications to patients while maintaining safety and efficacy standards.

This goal of minimizing redundant research also addresses the ethical considerations in clinical trials, ensuring that fewer resources are spent on unnecessary duplication of studies that do not contribute additional significant knowledge. As a result, the ICH facilitates a more effective and responsible approach to drug development on a global scale.