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Posted 05 November 2019 | By Michael Mezher 

ICH Updates: What to Expect Through 2020

2829 At a joint public consultation in Ottawa on Monday, officials from Health Canada and the US Food and Drug Administration (FDA) gave an overview of the progress made on more than two dozen International Council for Harmonisation (ICH) guidelines ahead of the upcoming ICH Assembly meeting in Singapore later this month.
The consultation comes roughly six months after FDA hosted the previous joint consultation with Health Canada in advance of the ICH Assembly’s meeting in Amsterdam last June.
During the consultation, officials from both agencies presented on guidelines at various stages of development, including two that had recently reached Step 3 of the ICH process and four that are expected to reach Step 4 of the ICH process in the near future.
Step 3: E8(R1) and E19
The two guidelines that recently reached Step 3 are E8(R1) and E19, both of which had reached Step 3 as of the previous consultation. Health Canada officials Carole Legare, director of the Office of Clinical Trials, Therapeutic Products Directorate, and Nashwa Irfan, associate director of the Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, gave overviews of the two guidelines.
The E8(R1) guideline is the first revision to ICH’s guideline on general considerations for clinical trials and introduces quality by design principles and critical to quality factors to the guideline.
Last week, ICH held a public meeting on E8(R1) to gather input on the draft version of the guideline released in May from groups not represented in ICH before the document is finalized.
“We still hope to have a Step 4 document by June 2020,” Legare said after noting that the E8 expert working group will need to review the comments received from the public meeting and make any necessary revisions.
For the E19 guideline, Irfan said the goal of the guideline is to “reduce the collection of non-serious adverse events or other safety data when the safety profile of the drug is known,” by explaining when a selective approach to safety data collection is appropriate.
Irfan said the results of the consultation on E19 will be discussed this month in Singapore, with Step 4 adoption expected in June 2020.
Expected to Reach Step 4: E9(R1), M9, Q12, S5(R3)
The four guidelines expected to reach Step 4 at the ICH Assembly meeting in Singapore this month are the addendum to E9(R1), M9, Q12 and S5(R3).
The addendum to E9(R1) presents a framework for defining an appropriate estimand for a clinical trial and conducting sensitivity analyses. According to Catherine Njue, biostatistics advisor at the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics within Health Canada’s Biologics and Genetic Therapies Directorate, the final version of the addendum has been revised from the draft version to include the treatment as one of the attributes that should be factored in the estimand.
The M9 guideline, which discusses biopharmaceutics classification system-based biowaivers has also been revised since the Amsterdam meeting to include a third annex providing questions and answers to clarify aspects of the guideline.
For the Q12 guideline, which covers technical and regulatory considerations for pharmaceutical product lifecycle management, Anthony Ridgway, senior regulatory scientist at the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics at Health Canada, noted that revisions had been made since the Amsterdam meeting and said that there are still some concerns about implementing certain aspects of the guideline in some regions.
The step 3 version of the S5(R3) guideline on the detection of toxicity to reproduction for human pharmaceuticals is also expected to be signed off on in Singapore after updates were made to annexes 1 and 2 of the guideline, which cover animal studies and alternative studies.
Ongoing and New Guidelines
Next up, Leo Bouthillier, Director, Bureau of Cardiology, Allergy and Neurological Sciences in the Therapeutic Products Directorate at Health Canada, gave a status update on 14 ongoing topics and work areas.
The topics include:
Guideline/Work Item Topic Status
E11A Pediatric Extrapolation Step 2 guideline anticipated in November 2020
E14/S7B Q&A Clinical and Non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential First stage Q&As anticipated to be finalized in May 2020
E17 Training Materials Multi Regional Clinical Trials Seven training modules available on ICH website
M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
  • M7 Addendum – draft version of monographs anticipated in 2020
  • M7 Q&A anticipated by the end of 2019
M10 Bioanalytical Method Validation Final guideline anticipated November 2020
M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) Draft guideline anticipated in June 2020
S1(R1) Revision on Rodent Carcinogenicity Studies for Human Pharmaceuticals
  • Review underway of carcinogenicity assessment documents
  • S1 may be revised based on results of the review
Q3C(R8) Maintenance of Guideline for Residual Solvents Draft guideline for three new solvents anticipated by end of 2019
Q3D(R1/R2) Maintenance of Guideline for Elemental Impurities Draft appendix anticipated by end of 2019
Q13 Continuous Manufacturing (CM) of Drug Substances and Drug Products Draft guideline for Step 2 anticipated June 2020
Q2(R2)/Q14 Analytical Procedure Development and revision of Q2(R1) Analytical Validation
  • Draft guideline anticipated June 2020
  • Potential for guidelines to be merged in the future
Q11 Q&A Training Materials Selection & Justification of Starting Materials Recently published on ICH website
E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
  • Revised Q&A document signed off in June 2019
  • Training modules being developed
  • EDQM User Guide to be updated
M8 EWG Electronic Common Technical Document (eCTD) Updated materials and documentation for eCTDv4
M2 EWG Electronic Standards for the Transfer of Regulatory Information (ESTRI) White paper being developed being M8 and E2B expert working groups on HL7 Fast Healthcare Interoperability Resources Standard
New Topics and Revisions
Lastly, Celia Lourenco, Director General of the Biologics and Genetic Therapies Directorate at Health Canada, presented information about six new topics that ICH has recently started work on, all of which are in early stages of development.
The informal working groups for each topic are expected to finalize their respective concept papers and business plans at the meeting in Singapore later this month.
Guideline Topic
E6(R3) Good Clinical Practice
E2D(R1) Postapproval Safety Data Management
E20 Adaptive Clinical Trials
M12 Drug Interaction Studies
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
S12 Nonclinical Biodistribution Studies for Gene Therapy Products
Meeting Agenda


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