ICH stakeholders contemplate initiative’s future upon its 30th anniversary

Regulatory NewsRegulatory News | 25 October 2021 |  By 

The International Council for Harmonisation (ICH) has issued a 30th anniversary publication that reflects on its history and surveys stakeholders to see where they see the initiative headed in the future.
Most stakeholders who answered the question saw ICH taking an expanded role in addressing the challenges posed by international health products and systems.
“Over the next ten years, ICH is well placed to forge and strengthen strategic partnerships among industry, regulators and academia to effectively develop guidelines addressing key contemporary issues and advance regulatory science,” John CW Lim, executive director at the Centre of Regulatory Excellence, Duke-NUS Medical School in Singapore, wrote in the publication. “Expanding membership will create a more inclusive stakeholder community and provide a strategic platform for advocating regulatory convergence, cooperation and collaboration.” 
Another area of expansion is through further inclusion of patient voices earlier in the drug development process, which will help aid “enhanced quality, relevance, safety and efficiency of drug development processes, to informed regulatory decision-making and, in consequence to the faster access to high quality, safe and effective medicines,” according to Joerg Schlaepfer, head of sector management services and international affairs at Swissmedic.
“Despite the clear and strong desire to advance on this topic, finding the right parameters and mechanisms to make it a reality are still a challenge,” Patricia Oliveira Pereira Tagliari, deputy director, Second Directorate of ANVISA in Brazil, wrote.
When asked about how ICH could improve its impact, stakeholders focused on the need to ensure guidelines were constantly evolving and adopted by new ICH members. This includes training, diversity, stakeholder engagement, optimizing strategic alliances, and an emphasis on working with lower- and middle-income countries.
ICH has created more than 60 guidelines since its inception, the stakeholders said. Beyond 2030, the initiative should move forward to create efficiencies in how guidelines are developed to free up resources, implement guidelines simultaneously that allow for drug development and review to occur in different regions simultaneously, adopt digital tools to facilitate improved data analytics and review, promote more diverse representation in clinical trials, and continue to build partnerships with related international organizations, noted Wassim Nasabeh, global head of regulatory policy and international operations at Roche; Milton Bonelli, scientific advice officer with the European Medicines Agency; and Richard Moscicki, chief medical officer at PhRMA.
“This is a tall order with goals not easy to achieve, but ICH is well practiced in charting an innovative journey in the service of public health. Doing this will ensure that ICH will continue to excel in the service of patients and populations worldwide,” they said.
ICH 30th Anniversary Publication


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you