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.
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