ICH first began as the International Conference on Harmonisation, started in 1990 by pharmaceutical regulatory agencies and industry associations of Europe, Japan and the US.
Building on a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development and regulation, ICH was formally restructured in 2015 as a Swiss non-profit association, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ICH has continued to grow and now represents regulators and industry associations from six continents.
For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in national laws, regulations and guidelines for reporting and evaluating data on the safety, quality and efficacy of new medicinal products.
The pharmaceutical industry was also becoming more international and seeking new global markets. However, the differences in technical requirements from country to country meant that the industry had to duplicate time-consuming and expensive test procedures to market new products internationally.
The need to rationalise and harmonise pharmaceutical regulation was driven by concerns over the rising costs of health care and research and development (R&D), and growing expectations from the public that there should be a minimum of delay in making safe and effective new treatments available to patients in need.
The harmonisation of regulatory requirements between different countries was pioneered by the European Commission (EC) in the 1980s, as the EC, Europe 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 discussions between Europe, Japan and the US on possibilities for harmonisation between their regions. At the WHO Conference of Drug Regulatory Authorities (ICDRA) in Paris in 1989, specific plans for action began to materialise. Soon afterwards, the authorities approached the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.
The birth of ICH took place at a meeting in April 1990, hosted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily to plan an international conference but also to discuss the wider implications and terms of reference of ICH.
At the first ICH Steering Committee meeting, the terms of reference were agreed and it was decided that the topics selected for harmonisation would be divided into the categories of safety, quality and efficacy to reflect the three criteria that are the basis for approving and authorising any new medicinal products.
ICH’s guideline harmonisation work has gradually evolved over the years. The first decade saw significant progress in the development of safety, quality and efficacy guidelines. Work was also undertaken on several important multidisciplinary topics, including MedDRA (Medical Dictionary for Regulatory Activities) for drug safety surveillance and reporting, and the CTD (Common Technical Document), which standardised the format for assembling quality, safety and efficacy data in new drug applications.
In its second decade, at the start of the new millennium, ICH began to increase communication and dissemination of ICH guidelines in new regions. ICH continued to develop new harmonised guidelines and revise existing guidelines as science and technology evolved, and facilitated the implementation of guidelines in the three founding “ICH regions”.
Now in its fourth decade of activity, ICH has a greater focus on extending the benefits of harmonisation beyond the founding ICH regions. In 2015, ICH underwent a series of organisational changes and reforms to increase international outreach, revise ICH’s governance, increase transparency on ICH processes and establish ICH as a legal entity to provide for a more stable operating structure.
The resulting non-profit ICH association, registered in Switzerland, establishes an Assembly as the overarching governing body with the aim of focusing global pharmaceutical regulatory harmonisation work. The revised structure allows both regulators and industry organisations to be actively involved in ICH’s harmonisation work. However, only regulatory authorities can give final approval to ICH guidelines.