Overview

A client developing a small molecule oncology treatment required G&L Healthcare Advisors' expertise for the submission of both a New Drug Submission (NDS) and a Supplemental New Drug Submission (SNDS) to Health Canada.

The client needed support to ensure their documentation was aligned with Canadian regulatory requirements, as well as guidance on preparing for and managing Agency meetings.

Following the NDS submission, G&L was further engaged to provide strategic support for the SNDS, including regulatory strategy development, meeting facilitation, and labeling negotiations with Health Canada.

Challenges

The client encountered several challenges while preparing to bring their oncology treatment to the Canadian market:
Compliance with Canadian regulations: The client’s documentation needed to be thoroughly reviewed and aligned with Health Canada’s specific regulatory requirements, which differ from other jurisdictions.
Agency engagement preparation: Preparing for meetings with Health Canada required expert knowledge to structure meeting requests, prepare meeting packages, and respond effectively to post-meeting questions.
Labeling negotiations: Ensuring that labeling precautions did not negatively impact the product's marketability required strategic negotiation and positioning with Health Canada.

G&L’s Approach and Solution

G&L provided a full suite of regulatory and clinical services to guide the client through both the NDS and SNDS submission processes and Health Canada engagements. Key activities included:
Gap analysis: G&L conducted a comprehensive gap analysis of the client's provided documentation, identifying any discrepancies with Canadian regulatory standards and addressing them accordingly.
Preparation of Module 1: G&L assisted in the preparation of Module 1 documents, including country-specific forms, environmental assessments, labels, Clinical Summary of Biopharmaceutical Evaluation (CSBE), and data sets tailored to Health Canada's requirements.
Review and positioning of key modules: G&L reviewed Modules 2.5 (Clinical Overview) and 2.7 (Clinical Summaries) along with the Quality Overall Summary (QOS) to ensure alignment with Canadian regulatory standards. G&L also conducted a thorough review of Modules 3 (Quality) and 5 (Clinical Study Reports) to ensure compliance.
Agency meeting support: G&L prepared the client’s team for meetings with Health Canada, including preparing meeting requests and meeting packages.
G&L also provided strategic input during post-meeting responses and label negotiations.
Regulatory strategy for SNDS: For the SNDS, G&L developed a strategic plan and negotiated directly with Health Canada, leveraging regulatory intelligence and precedent to avoid labeling warnings and precautions that could have negatively impacted the product’s commercial positioning.

Impact and Outcomes

Through G&L's support, the client achieved significant regulatory and market outcomes:
Successful Agency meetings: The client successfully navigated Health Canada’s requirements, gaining endorsement for their submission plans during productive Agency meetings.
Timely submissions: The client’s NDS and SNDS were submitted on time, in full compliance with Health Canada regulations.
Effective labeling strategy: G&L’s negotiation strategy avoided the need for serious warnings and precautions on the product’s labeling, improving its market positioning.