ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

The International Council of Harmonization (CIE) is considering two new issues, according to the report published Thursday at the group's Montreal meeting in May and June.

Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).

The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.

During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.

Progress in other guidelines

The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.

For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.

The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.

ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.

Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.

The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.

During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.