Argentina, Israel, Jordan And Saudi Arabia Join ICH As Observers
Executive Summary
The International Council for Harmonisation appointed more observers at its latest meeting in Amsterdam and identified several new topics on which it plans to issue harmonized guidelines.
Drug regulatory agencies in Argentina, Israel, Jordan and Saudi Arabia became the latest organisations to join the International Council for Harmonisation as observers. Their appointment was confirmed this month at the council's "largest biannual meeting to-date" in Amsterdam, bringing the total number of ICH observers to 32.
As observers, Argentina’s ANMAT, Israel’s CPED, Jordan’s JFDA and Saudi Arabia’s SFDA will be able to attend the meetings of the ICH Assembly without voting rights. They will also be able to appoint experts in working groups following a positive decision of the ICH management committee.
The ICH meeting took place on 1-6 June and was attended by almost 500 delegates, where the ICH discussed its upcoming global meeting where it plans to make progress with its much-publicized project on "renovating" its good clinical practice (GCP) guidelines. (Also see "ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources" - Pink Sheet, 24 Feb, 2017.)
The global meeting is scheduled to take place on 31 October in Maryland, in the US, and will be open to public stakeholders. The ICH plans to discuss the next steps regarding its recently revised E8 guideline on general consideration for clinical trials. (Also see "ICH Plans Revamp Of Guidance On Clinical Trial Data Quality" - Pink Sheet, 13 May, 2019.) The council also plans to hold additional stakeholder meeting in ICH members/regions on this topic, including one in Tokyo, Japan, on 25 July.
At the Amsterdam meeting, the ICH reviewed work on updating existing guidance document and also gave its nod to several new topics for harmonization. Specifically, it endorsed a strategic reflection paper on harmonized requirements for pharmacoepidemiological studies submitted to regulatory agencies to advance more effective utilization of real-world data. The ICH intends to publish the paper online and establish a discussion group on this topic.
It also agreed to begin work on new topics relating to:
1) Q5A(R2) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin: This would update the ICH's existing Q5A Guideline on technologies for virus detection and quantification, and validation approaches for virus clearance, and expand the document’s scope to include new biotechnology products such as viral-like particles and viral-vectored particles.
2) E6(R3) Guideline for good clinical practice: This would revise the ICH's E6(R2) guideline to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, and bring the guideline in line with its reflection paper on GCP renovation.
3) E2D(R1) Post-approval safety data management - Definition and standards for expedited reporting: This would update the ICH's E2D guideline to incorporate pragmatic, potentially risk-based approaches for the management of information from existing and any new data sources, to enable a greater focus on the data sources that will optimize signal detection activities and public health.
4) A new guideline on non-clinical biodistribution studies for gene therapy products: This would recommend the types of non-clinical studies with which collecting biodistribution data is considered informative and/or necessary to support dosing in early clinical trials. The guideline would offer advice on the design of such studies. It is expected to help streamline the development of gene therapy products with higher scientific rigor while minimizing the unnecessary use of animals.
5) A new guideline on impurity – assessment and control of extractables and leachables (E&L) for pharmaceuticals and biologics: The guideline would establish a workflow for assessing leachables in all drug product dosage forms. The workflow would include evaluation and reporting thresholds linked to the route of administration, duration of exposure and dose-response concepts.
While work on the first four guidelines is to begin immediately and will involve the ICH establishing working groups to develop formal concept papers and business plans, work on the final guideline will start later at a date that is still to be determined.
Uptake Of ICH Guidelines
The ICH also presented the results of a survey designed to better understand the state of implementation of ICH guidelines by its regulatory members and observers. (Also see "ICH Evaluates Guideline Uptake By New And Old Members " - Pink Sheet, 13 Aug, 2018.) A communication on the aggregated survey results is to be published on the ICH website later this year.