Update on Health Canada’s Implementation of ICH’s Q12 Guideline and Pilot Programs

Health Canada has published an update on Update on the Implementation of ICH’s Q12 Guideline and Pilot Programs.

What is the ICH 12 guideline about?

The ICH guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.

The expected benefits of implementing the ICH guideline

Implementation of ICH’s Q12 Guideline will:

  • promote innovation and continual improvement in the biopharmaceutical and pharmaceutical sectors and strengthen quality assurance and reliable product supply, including proactive planning of supply chain management.
  • allow regulators (assessors and inspectors) to better understand a firm’s Pharmaceutical Quality Systems (PQSs) for the management of post-approval CMC changes.
Opportunity for a limited number of applicants to participate in two pilot programs

As part of Health Canada’s (HC) implementation of ICH’s Q12 guideline, it has announced the opportunity for a limited number of applicants to participate in the following two pilot programs:

1. ICH Q12 Established Conditions and Post Approval Change Management Protocol Pilot Program (ICH Q12 Pilot Program):

This Pilot Program is specifically seeking Supplements to New Drug Submission (SNDS) applications for biologics and radiopharmaceuticals and New Drug or Abbreviated New Drug Submissions (NDSs or ANDSs) or Supplements (S(A)NDSs) for pharmaceuticals that will employ the use of established conditions (ECs) and/or Post Approval Change Management Protocols (PACMPs).

Only NDSs with 180 day TPD targets will be accepted. HC’s goal in implementing this Pilot Program is to gain experience in receiving, assessing, and engaging with applicants regarding proposed ECs and/or PACMPs.

Deadline for submitting Expressions of Interest (EOI)

HC will accept EOIs from applicants planning to submit proposed ECs and/or PACMPs, on or before December 6, 2021.

2. Immediate Notifications for Pharmaceuticals Pilot Program

The filing of Immediate Notifications for pharmaceuticals, as described in the draft post-NOC changes quality guidance document currently out for external consultation, will also be accepted as a separate Pilot Program (Immediate Notification Pilot Program) which will run concurrently.

Deadline for submitting Expressions of Interest (EOI)

EOIs to submit an Immediate Notification will also be accepted on or before December 6, 2021. The Immediate Notification(s) for this pilot program should be filed between December 6, 2021 and March 7, 2022

Further information

Further information available on the HC website, here.

Source: Health Canada website