ICH charts new topics, touts progress in updating existing guidelines
The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics and bioequivalence studies for modified release products. The group also touted the release of long-awaited updates to older guidelines in a 20 June announcement following its 12 June meeting in Vancouver, Canada.ICH announced that a new efficacy guidance, General Considerations for Patient Preference Studies, will address the design, analysis and submission of these studies to supplement information about a product or to inform drug development.
Plans are also in the works to develop a new safety guideline, Nonclinical Safety Studies for Oligonucleotide-based Therapeutics, to clarify regulatory expectations on the nonclinical evaluation of oligonucleotide-based treatment options. ICH also plans to develop a new multidisciplinary guide, Bioequivalence for Modified-Release Products, to harmonize bioequivalence standards for more complex dosage forms.
In other new areas, ICH plans to advance a new reflection paper on harmonizing real-world evidence (RWE) terminology and general principles for planning and reporting studies using RWD. The harmonization body also plans to launch a new cell and gene therapies discussion group (CGTDG) that will serve as a technical forum on these topics. The group plans to develop a roadmap of potential areas of harmonization.
Milestones reached
ICH announced that “significant milestones” were reached on “eagerly awaited” updates to several older guidelines and two draft guidelines.
This includes the release of the final revised ICH M7(R2) guideline, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, that aims to harmonize the framework for assessing and controlling DNA mutagenic impurities; the guideline was adopted in at Step 4 of the ICH process in April 2023. (RELATED: ICH adopts My(R2) guideline on mutagenic impurities to limit carcinogenic risk, Regulatory Focus 7 April 2023)
Another noteworthy achievement was the sign off on the ICH S12 guideline, Nonclinical Biodistribution Considerations for Gene Therapy Products, in March 2023; the guidance covers nonclinical biodistribution studies in the development of gene therapy products. (RELATED: ICH adopts S12 guideline for gene therapies, Regulatory Focus 20 March 2023)
The draft guidelines include the update to ICH’s Good Clinical Practice (GCP) guideline, E6(R3), which was endorsed as a Step 2 document in May 2023. (RELATED: FDA seeks feedback on ICH E6(R3) GCP guideline, Regulatory Focus 6 June 2023)
The other draft guideline is the draft ICH M13(A) guideline, Bioequivalence for Immediate-Release Solid Oral Dosage Forms, which aims to harmonize bioequivalence requirements for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to systemic circulation, such as tablets, capsules and granules for oral suspension. It was endorsed as a Step 2 document in December 2022.
MEDDRA growth noted
In other areas, ICH reported that Medical Dictionary for Regulatory Activities (MedDRA) experienced 11% growth last year compared to the previous year. MedDRA is now available in 19 languages, and now has over 8,300 users in 134 countries.
ICH also announced that Egypt’s Egyptian Drug Authority (EDA) has joined as the first African regulatory member. Also, Nigeria’s National Agency for Food and Drug Administration (NAFDAC) has joined as a new observer, bringing the number of ICH members to 21 members and 36 observers.
The next ICH Assembly meeting will be 3 October 2023 in Prague, the Czech Republic.
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