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…