ICH M4 (Technical Requirements for Registration)

ICH M4 is a guideline that outlines the technical standards and documentation needed for registering medicines across different countries. It ensures that pharmaceutical products are safe, effective, and of consistent quality. The guideline details how to develop, verify, and submit the necessary data and information about a drug, including its manufacturing process and quality controls. By standardizing these requirements, ICH M4 helps streamline the approval process internationally, facilitating access to new medicines while maintaining safety and reliability.