On March 26, 2020 the FDA encouraged International Regulatory Harmonisation “a process where[global] regulatory authorities align technical requirements for the development and marketing of pharmaceutical products….to support early access to medicinal products, promoting competition and efficiency, and reducing unnecessary duplication of clinical testing.”  Asking them to implement the ICH Guidelines.

The International Conference on Harmonisation (ICH) for the Technical Requirements for Registration of Pharmaceuticals for Human Use has been around since April 1990, the FDA is a founding member of ICH.

On October 23, 2015 formally became The International Council for Harmonisation establishing ICH as an international association with members, and a legal entity under Swiss law.  They areunique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration…has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide.”