Posted 08 February 2017
By Zachary Brennan
The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.
New members approved at the meeting were Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the US industry group Biotechnology Innovation Organization (BIO) and Korea’s Ministry of Food and Drug Safety (MFDS).
In terms of observers, ICH’s Assembly, after the applications were approved by the management committee, approved the addition of the Active Pharmaceutical Ingredients Committee (APIC), Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED, Cuba), the Medicines Control Council (MCC, South Africa) and the National Center for the Expertise of Drugs, Medical Devices and Equipment, (National Center, Kazakhstan).
The Assembly discussed two topics, proposed by the US Food and Drug Administration (FDA) and Japan Pharmaceutical Manufacturers Association (JPMA), as potential strategic topics: “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6; and Compliance of Reliability for Electronic Records, and confirmed support for the next steps from this discussion.
The Assembly supported the reflection paper on GCP Renovation and noted a feasibility group will be set up to further consider the reflection paper on Compliance of Reliability for Electronic Records ahead of the June 2017 meeting in Montreal.
ICH also offered status updates on dozens of draft guidelines progressing with the help of expert working groups (EWGs) to Step 2a/b and Step 4.
S5(R3) EWG, which is working on a revision to guidance on “Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility,” aims to finalize a Step 1 document in Q2 2017.
In terms of progress toward developing the draft S11 guideline, “Nonclinical Safety Testing in Support of Pediatric Drug Development,” the Assembly suggested the need for additional detail and specificity in the current draft text and noted the need to submit a revised work plan and timeline for reaching Steps 2a/b and Step 4.
For the draft Q12 technical document, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” the Assembly noted the Q12 EWG’s request for an interim meeting in April 2017 to continue progress on finalizing the Step 1 document in order to reach Step 1 and Step 2a/b in June 2017.
The E9(R1) EWG is looking to conduct some internal consultation on the draft currently being developed ahead of the spring ICH meeting and it will make a proposal on whether non-statisticians will need to support the group in reviewing the draft technical document.
On updating the draft E17 Guideline on “Multi-Regional Clinical Trials,” the Assembly noted that the E17 EWG expects to reach Step 3 sign off and Step 4 adoption in Q4 2017. Similarly, the E18 EWG, updating the draft Guideline on “Genomic Sampling and Management of Genomic Data,” expects to reach Step 3 sign off and Step 4 adoption in Q2 2017.
The M9 EWG, developing the draft guideline on “Biopharmaceutics Classification System-based Biowaivers,” expects to reach Step 1 by the spring 2018 meeting.
The M10 EWG, developing the draft guideline on “Bioanalytical Method Validation,” said it would prepare the first draft technical document after the meeting in Japan.
The ICH S9 implementation working group (IWG) is expected to reach Step 3 and Step 4 by June 2017 for its question and answer document on “Nonclinical Evaluation for Anticancer Pharmaceuticals.”
The Q3C(R6) regulatory experts signed off Step 3 of the Q3C(R6) Guideline on “Maintenance of the Guideline for Residual Solvent” in advance of the Assembly meeting.
And the Q3D(R1) EWG, working on a guideline on elemental impurities guidance, has updated its concept paper and will begin developing Permitted Daily Exposure levels and permitted concentrations of elemental impurities for products administered by the cutaneous and transdermal routes of administration following confirmation of the experts participating in the EWG.
Q11 Experts signed off on Step 1 of the Q11 Q&As on API Starting Materials (via written postal procedure) in advance of the Assembly meeting.
The E6(R2) Regulatory Experts signed off on Step 3 of the Integrated Addendum to Good Clinical Practice in advance of the Assembly meeting, while the E11(R1) EWG and the E14/S7B discussion group said they will provide work plans to the MC ahead of teleconferences in spring 2017.
The Assembly noted the current activities of the S1 EWG, which did not meet in Japan, including the progress made toward the collection and review of confidential submissions of Carcinogenicity Assessment Documents (CADs) and summary report submissions by sponsors to Drug Regulatory Authorities (DRAs) within each region and considerations regarding the timeframe for drafting the S1 technical document on rodent carcinogenicity studies for human pharmaceuticals.
Progress was also explained on completing a document on how to use the EDQM Routes of Administration; progress toward an editorial update to the Implementation Guide to reflect the Q&A document; and progress toward the determination of any conflicts in individual case safety report (ICSR) messages based upon review of regional implementation guides.
The Assembly also adopted the concept paper outline on Optimization of Safety Data Collection (code: ICH E19) and agreed on the establishment of an informal working group (with FDA nominated as lead) to finalize the paper and develop a business plan ahead of the management committee’s teleconference in spring 2017.
The next ICH meeting will be held in Montreal from 27 May to 1 June.
MEETING MINUTES ICH Assembly 9 – 10 November 2016, Osaka, Japan