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

November 5, 2021
Our file number: 21-115313-479

Summary

International Council for Harmonisation’s 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. Implementation of ICH’s Q12 Guideline will promote innovation and continual improvement in the biopharmaceutical and pharmaceutical sectors and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain management. It will allow regulators (assessors and inspectors) to better understand the firm’s Pharmaceutical Quality Systems (PQSs) for the management of post-approval CMC changes.

As part of Health Canada’s (HC) implementation of ICH’s Q12 guideline, we are pleased to announce the opportunity for a limited number of applicants to participate in the following 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.
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 (EOIs)

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

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.

Requests to participate

We invite sponsors who are interested in participating in the ICH Q12 Pilot Program, and who plan to propose ECs and/or PACMPs in an upcoming application, to submit an expression of interest to the ich@hc-sc.gc.ca mailbox. Please include "ICH Q12 Pilot Program for ECs and/or PACMPs " in the subject line.

Sponsors who are interested in participating in the Immediate Notification for Pharmaceuticals Pilot Program, are invited to submit an expression of interest to the bpsenquiries@hc-sc.gc.ca mailbox. Please include “Immediate Notification for Pharmaceuticals Pilot Program” in the subject line.

The EOIs should also include the following items:

1. The contact person's name, company name, and company contact information.
2. The brand and non-proprietary names of the proposed drug product and a brief description (e.g., dosage form, indication).
3. Type of product (e.g., blood, vaccine, anti-cancer drug, pharmaceutical).
4. Scope of application (e.g., the changes that are covered by the proposed protocol or notification).
5. Extent of sponsor’s experience using ICH Q8-Q11 principles.
6. Whether the proposed submission will be based on limited data or will use platform knowledge.
7. Plans for any pre-submission meetings to take place prior to filing the submission for the ICH Q12 Pilot Program for ECs and/or PACMPs . Requests for such meetings should follow previously established procedures as outlined in relevant guidance documents.
8. The expected timing for submission of the application. Please note that the submission of an EC and/or PACMP and for an Immediate Notification should be planned for receipt by HC no later than March 6, 2022.
9. Acknowledgement that participation in either Pilot Program may be discontinued if the manufacturing facilities named in the application are not in a state of compliance with Good Manufacturing Practices (GMPs) at the time of the submission.

HC intends to accept a limited number of requests from sponsors that have an established Pharmaceutical Quality System in place, meet the above-mentioned criteria, and represent a variety of product types. HC expects to notify sponsors of its decision regarding acceptance into either Pilot Program, in writing, within 30 days of the deadline to submit the expression of interest. Please note that HC may automatically screen out incomplete and/or unclear requests; however, HC reserves the right to contact the applicant to request additional information.

HC encourages applicants who are accepted in the ICH Q12 Pilot Program for ECs and/or PACMPs to pursue pre-submission meetings through existing mechanisms.

Contact information

For additional information, or to submit your expression of interest, please contact:

For ICH Q12 Pilot Program for ECs and/or PACMPs:
Health Canada - ICH Coordinator
ich@hc-sc.gc.ca

For Immediate Notification for Pharmaceuticals Pilot Program:
Health Canada – BPS Enquiries
bpsenquiries@hc-sc.gc.ca