We’re delighted to announce that we’ve been selected by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) to undertake an assessment of regulatory agencies’ and companies’ perspectives on the implementation and adherence to ICH guidelines. This study will build on methods developed in the 2019 study, with an additional aim to assist the ICH Management Committee in determining whether regulatory members would meet the eligibility criteria for committee elections in June 2021. The study will also serve as a reference to allow participating observers interested in future ICH membership to confirm their eligibility.

CIRS first became involved with ICH in the 1990s, under our previous name of Centre for Medicines Research (CMR) International. As well as contributing to several ICH working parties including in the areas of toxicity and efficacy, we conducted a study amongst leading pharmaceutical companies to assess the impact of ICH efficacy guidelines on global clinical development (CMR International, 1997).

“As the Executive Director of CMR International, I was privileged to have been invited to participate in five ICH working parties, which included initiatives that had a major impact in reducing the number of animals used in pre-clinical development and streamlined clinical development. Our contribution was because of the data that we were able to obtain from European, American and Japanese pharma companies, which provided the evidence base for significant changes that resulted in the harmonisation of regulatory requirements.

The 1990s was one of the most transformational decades in the history of medicines development and review because of groups like ICH, industry associations and others working together. Given the unprecedented global health challenges we face today, collaboration and cooperation are more important than ever.”

Professor Stuart Walker, Founder of CIRS

We’d like to take this opportunity to congratulate ICH on its 30-year anniversary. ICH has played a fundamental role in bringing regulators and industry together to discuss technical aspects of pharmaceuticals and develop guidelines. This has led to greater harmonisation worldwide, helping to ensure that safe, effective and high-quality medicines are developed and registered in an efficient manner.