The European Commission pioneered the harmonization concept of pharmaceuticals in the 1980s as it moved towards developing a single market. Observing the success of this, discussions began between the United States, Europe, and Japan to explore the possibility of harmonization.
During the World Health Organization’s Conference of Drug
Regulatory Authorities in 1989 in Paris, an action plan was drawn up for this
harmonization. Drug authorities then reached out to the International
Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to decide
about an international, joint industry-regulatory body initiative.
In April 1990, a meeting was held in Brussels, resulting in
the birth of ICH. Representatives of industry associations and regulatory
agencies in Europe, the US, and Japan met to plan an International Conference.
During the first Steering Committee meeting of ICH, the
stakeholders reached an agreement about the terms of reference. They decided
that the three criteria on which approval and authorization for new medicines
would be given would be Quality, Safety, and Efficacy. It was agreed that
harmonization would focus on topics falling under these three critical
criteria.
Over the years after its inception, ICH has evolved and
grown to make greater harmonization possible to ensure the development of
effective, safe, high-quality medicines and their easy registration.
The ICH also developed the concept of the Common Technical
Document (CTD) and Medical Dictionary for Regulatory Activities (MedDRA).
One of the biggest successes of ICH was the introduction of
the concept of Quality by Design (QbD) to the pharmaceutical industry in 2009.
Organizational changes were made in October 2015 and now,
ICH comprises 16 Members and 32 Observers.
Founding Members of ICH:
Member countries: United States, Japan, and the European
Union
Regulatory Representatives:
1. European Commission (EC) and European Medicines Agency
(EMA).
2. United States Food and Drug Administration (USFDA).
3. Japan’s Ministry of Health, Labour and Welfare (MHLW).
Industrial Representatives:
1. EU’s European Federation of Pharmaceutical Industries and
Associations (EFPIA).
2. USA’s Pharmaceutical Research and Manufacturers of
America (PhRMA).
3. Japan’s Pharmaceutical Manufacturers Association (JPMA).