ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

Posted 29 September 2017 By Michael Mezher

placeholder+image

The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June.

The two topics include the first revision to ICH's 1997 E8 General Considerations for Clinical Trials and a new guideline on pediatric extrapolation in clinical trials, both proposed by the US Food and Drug Administration (FDA).

The ICH Assembly also adopted concept papers outlines for both topics and nominated FDA to lead the informal working groups tasked with finalizing the concept papers and developing business plans for moving forward with the guidelines.

During the meeting the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a new regulatory member and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) as an observer to the group.

Progress on Other Guidelines

The minutes also detail updates presented to the ICH Assembly on other guidelines in various stages of development or revision.

For ICH's ongoing revision of its guideline on rodent carcinogenicity studies, ICH S1(R1), the expert working group (EWG) rapporteur told the assembly that 40 carcinogenicity assessment documents and summary report submissions were collected from regulatory authorities and that the document is expected to reach Step 2a/b in June or November 2018.

The EWG for ICH's upcoming guideline on nonclinical safety testing for pediatric medicines (S11) also reported that it expects to finalize a Step 1 document ahead of the ICH meeting in Geneva, Switzerland in November.

ICH's E17 guideline on multi-regional clinical trials is also expected to reach Step 3 at the Geneva meeting, and could possibly reach Step 4 at the meeting depending on the outcome of a 5-6 day meeting aimed at going over comments on the guideline.

For ICH's Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, the Assembly noted that the Step 1 document still needs to go through a legal review for the EU that was expected to be completed by mid-September 2017 before members could decide on endorsing the document for Step 2.

An update was also provided by the informal working group on the planned E19 guideline on optimizing the collection of safety data, which noted that the guideline is expected to reach Step 1 in November 2018.

During the meeting, the ICH Assembly also endorsed the work plans for the E2B(R3) guideline on electronic submission of individual case safety reports, the M2 guideline on electronic standards for the transfer of regulatory information, M9 guideline on biopharmaceutics classification system-based biowavers and the M10 guideline on bioanalytical method validation. The M9 and M10 guidelines are also expected to reach Step 1 by June 2018.

ICH Assembly Minutes, Management Committee Minutes

Share this article:

Categories: Biologics and biotechnology, Drugs, Clinical, Quality, News, ICH

Tags: ICH Assembly, Montreal, E8(R1), Pediatric Extrapolation

Regulatory Exchange: Latest Updates From the Community