The birt of the International Conference on Harmonisation (ICH) took place at a meeting in April 1990, hosted by the European Federation of Pharmaceutical Industries’ Associations (EFPIA) in Brussels. “Representatives of the regulatory agencies and industry associations of Europe, Japan and the USA met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.” [3]
ICH is a “joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines.” [1, 2]
“Harmonisation of regulatory requirements was pioneered by the European Community, in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation. It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans for action began to materialise. Soon afterwards, the authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.” [3]
Country medical regulators work closely with the International Federation of Pharmaceutical Manufacturers Association (IFPMA)
On October 23, 2015 the regulation of medicine becomes “truly global initiative” where the organisation becomes the International Council for Harmonisation (ICH). [4]
From 2016 the WHO begins promoting Towards Access 2030 – which appears to be the precursor for a global regulator