The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met on June 12-13, 2023, and announced the formation of a cell and gene therapy discussion group, among other priorities for the global biopharmaceutical industry.
The 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,” explains Nancy Travis, VP of International Affairs at the Biotechnology Innovation Organization (BIO). She is 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,” added Travis.
The group will serve as a forum to discuss technical issues related to harmonization of cell and gene therapy products. The group will focus on modalities “of relatively high maturity.”
The discussion group will be comprised of experts from ICH members and observers who have “direct experience” in the development and/or regulatory review of CGTs. Over the next two years, the discussion group aims to develop a roadmap of potential areas of harmonization.
Why do we need regulatory harmonization?
Globally, there have been 99 approvals of 57 unique cell and gene therapy products between 1996 and 2021. And as the industry advances, more approvals could be coming, because there are currently 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, explained BIO in a presentation to ICH.
“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). (Dr. Nashabeh is BIO’s other representative to the ICH Management Committee and Assembly.)
What is the ICH?
Since its inception in 1990, ICH has brought together regulatory authorities and the pharmaceutical industry. The goal is greater harmonization in drug development in an increasingly global industry. The ICH was officially established as an international association in October 2015.
Following the June meeting in Vancouver, Canada, the ICH made additional announcements. These include:
- Three new topics of harmonization: “General Considerations for Patient Preference Studies,” “Nonclinical Safety Studies for Oligonucleotide-based Therapeutics,” and “Bioequivalence for Modified-Release Products.”
- A decision to advance a new ICH Reflection Paper, “International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines.”
- Approval of a new concept paper on the new ICH E21 Guideline, “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials.”
- Additional updates on the adoption and endorsement of several guidelines over the past six months, as well as updates on training materials and activities.
In addition, the ICH announced membership updates. The Egyptian Drug Authority is the first African Regulatory Authority to join ICH as a Member. In addition, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) is an ICH Observer.
The next ICH Assembly is scheduled for October 31-November 1 in Prague, Czech Republic.
