The International Council for Harmonisation (ICH) is the most successful pharmaceutical harmonisation project in the world. The key to this success has been good and effective collaboration between industry and authority experts in the ICH groups, which serves to elaborate on guidelines concerning quality, safety, efficacy and multidisciplinary topics, e.g. the electronic Common Technical Document (e-CTD).
More than 3 years ago, the European Commission questioned the governance, transparency, funding and international outreach of ICH. The other ICH parties, with the exception of EFPIA, were quite unwilling, at first, to change a winning formula. In addition to the – from a European perspective – reasonable requests for better governance, increased transparency and shared funding, the globalisation of ICH was an important objective for EFPIA during the work on the ICH reform.
After 3 years of discussion on ICH reform, we have now managed to increase transparency, improve the governance and put in place a system for the shared funding for the ICH activities.
At the ICH Conference in Jacksonville from 5 – 10 December 2015, the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, the regional harmonisation initiatives (RHI), the Southern African Development Community (SADC), the Gulf Cooperation Council (GCC), the Pan American Network for Drug Regulatory Harmonization (PANDRH), and the Asia-Pacific Economic Cooperation (APEC) were welcomed as the first Observers.
In June 2016, ICH will welcome its first new members from emerging markets. This means that drug regulatory authorities, and RHIs, which becomes members, have to implement the ICH guidelines. The implementation of ICH guidelines in emerging markets will greatly facilitate drug development, authorisation, maintenance and production in these markets. I therefore think that the creation of the new ICH as an independent association in the autumn of 2015, is a game changer for the pharmaceutical industry.