CIOMS guidelines have served as a basis for many ICH guidelines.

For example ICH E2A (1994): Clinical Safety Data Management Definitions and Standards for Expedited Reporting was based on the CIOMS I and II reports for marketed medicinal products (CIOMS, 1990 and 1992). ICH E2C (1996): Clinical Safety Data Management – Periodic Benefit-Risk Evaluation Reports (PBRER) described the specifications for format and content of periodic safety update reports (PSURs) and was based on the former work carried out by CIOMS II and CIOMS III reports (CIOMS, 1992, 1995). ICH E2D (2003): Post-Approval Safety Management – Definitions and Standards for Expedited reporting formalized the application of relevant elements of ICH E2A in the post-authorization phase and was based on the former work done by CIOMS V (CIOMS, 2001). ICH E2F (2010): Development Safety Update Reports was based on the CIOMS VIII report (CIOMS, 2006) and describes the specifications for format and content of development safety update reports (DSURs). Last but not least, the MedDRA Working Group (IWG) on Standardized Medical Queries (SMQs) based on MedDRA terminology is for the time being CIOMS’ “oldest” Working Group having started back in 2003. It was subsequently modified to a core group in 2008 before becoming an Implementation Working Group (IWG) in 2011. This IWG has produced the “Red Book” – the forthcoming update of the publication of the updated version of “SMQs Development and Rational Use of standardised MedDRA Queries” was published in 2016. In addition to CIOMS “Red book” two more important guidelines were published recently. First, Evidence Synthesis and Meta-Analysis for Drug Safety: Report of CIOMS Working Group X (2016). The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Second, CIOMS Guide to Active Vaccine Safety Surveillance (2017). This guide offers a practical step-by-step approach and algorithm to aid immunization professionals and decision-makers in determining the best course of action if additional vaccine safety data is needed. The Guide provides a structured process for evaluating whether significant knowledge gaps exist, whether passive safety surveillance is adequate, and if not, methods for and practical aspects of conducting active vaccine safety surveillance.