The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met last week and announced several developments, including the formation of a discussion group that’s been a priority for BIO members.
What is ICH? Since its inception in 1990, ICH has brought together regulatory authorities and the pharmaceutical industry to work toward greater harmonization in drug development in an increasingly global industry.
Let’s talk: The new ICH Cell and Gene Therapies Discussion Group (CGTDG) is “charged with developing a roadmap of potential harmonization areas, focusing on CGT modalities that are relatively mature,” says Nancy Travis, VP of International Affairs at BIO and one of BIO’s two representatives to the ICH Management Committee and Assembly. “The establishment of this group has been a goal of BIO since 2019.”
Why it matters: Globally, there have been 99 approvals of 57 unique CGT products between 1996 and 2021—and more are coming, with 2,220 active clinical trials globally. As more products are likely to come under regulatory review, it’s critical the industry advances a science-based regulatory framework across all regions to make clear development requirements and a path forward for sponsors.
What they’re saying: “This is a major milestone for the biotechnology community and a first critical step towards global regulatory harmonization of cell and gene therapy products at ICH,” said Wassim Nashabeh, Ph.D.. VP, Policy and International Operations, Pharma Technical Regulatory at Genentech, a member of the Roche Groupe (and BIO), and BIO’s other representative to the ICH Management Committee and Assembly.
Additional ICH announcements include:
- A new member (Egypt) and observer (Nigeria);
- Three new areas of harmonization, around patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics, and bioequivalence for modified-release products; and,
- Updates on the adoption and endorsement of several guidelines over the past six months, as well as training materials.
What’s next: Comprised of diverse experts from ICH members and observers with “direct experience” with the development and/or regulatory review of CGTs, the discussion group will, over the next two years, develop a roadmap of potential areas of harmonization. The next ICH Assembly is scheduled for October 31-November 1 in Prague.
Read the full announcement.
