About the S11 guidelines
The ICH guideline S11 focuses on nonclinical safety testing to support the development of paediatric pharmaceuticals. It was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration.
The primary objective of ICH S11 is to provide guidance on the appropriate scope and application of nonclinical safety studies to support the safe clinical development of pharmaceuticals intended for use in the paediatric population. This includes considerations for the timing, species selection, design, and execution of nonclinical studies to ensure that they provide meaningful safety information that can be used to cure paediatric patients.
About the ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global initiative that aims to bring together regulatory authorities and the pharmaceutical industry from different regions to discuss and establish common technical guidelines and standards for the development, registration, and post-approval changes of pharmaceuticals. The goal is to promote public health and ensure that safe, effective, and high-quality medicines are developed and registered in the most efficient and cost-effective manner.
The ICH guidelines serve as a unified standard that member regions (FDA in the United States, EMA in the European Union, and PMDA in Japan) agree to follow, which helps to ensure consistency and reduce the likelihood of major differences between regions, facilitate international collaboration, streamline drug development and approval, and support safe drug development. Member regions participate actively in the ICH process by contributing to the development and update of guidelines and committing to implementing these guidelines within their respective regulatory frameworks. Following the ICH guidelines in the development of a drug, it is therefore more likely to meet the regulatory requirements in all member regions, facilitating the international registration and availability of new drugs, including those intended for paediatric patients.
Retrieve the S11 guideline
Go to the EMA website for more information about the ICH S11 guidelines.
