Spring Intro 2023

03/03/2023

Regulatory Guidelines

9

The need for harmonisation of drug regulations came after preliminary contacts between officials from Japan, EU and US, discussed during the International Conference of Drug Regulatory Authorities in 1989 . These discussions revealed a need for the harmonisation of requirements relating to the new innovative drugs and led to the establishment in 1990 of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). (Now called International Council for Harmonisation) ICH meetings are still held twice a year and involve many more countries.

10