Ocrevus – Notice of Compliance with Conditions - Qualifying Notice
Biologics and Genetic Therapies Directorate
100 Eglantine Driveway
Address Locator #0601C
January 3, 2018
Dossier ID: HC6-024-e132363
Control #: 197969
Document #: 1281371
[Employee's name removed]
[Employee's title removed]
Hoffmann-La Roche Limited
7070 Mississauga Road
Fax: (905) 542-5678
Dear [Employee's name removed]:
This Notice of Compliance with Conditions (NOC/c)-Qualifying Notice, issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the New Drug Submission (NDS) for OCREVUS (ocrelizumab), Control Number 197969, indicated for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity, qualifies to be considered for authorisation under the NOC/c policy. In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment:
- A letter, signed by the Chief Executive Officer, or designated signing authority of Hoffmann-La Roche Limited, indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Hoffmann-La Roche Limited consents to the posting of the NOC/c-QN on Health Canada's website.
- A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority, of Hoffmann-La Roche Limited, having a form and content satisfactory to Health Canada, as indicated in the Guidance Document: Notice of Compliance with Conditions (NOC/c), including commitments to provide the following:
Conduct a new clinical study in patients with PPMS to confirm the efficacy and clinical benefit of OCREVUS. The proposed overview of the design of study WA40404 is acceptable, in principle; however, prior to conducting the trial, obtain concurrence from BGTD’s premarket Autoimmune-Endocrinology Clinical Evaluation Division (CED-AE) regarding the clinical trial design, efficacy endpoints, and other methodological consideration such as sample size and statistical analysis.
BGTD acknowledges that the Last Patient In (LPI) is expected to be enrolled in the study WA40404 in December 2021. Submit the final study report as an SNDS-C in a timely manner following study completion.
Acknowledge that the indication for PPMS may be withdrawn in the event of lack of clinical benefit of OCREVUS in patients with PPMS in study WA40404.
Progress Reports of Confirmatory Trials and Other Ongoing Trials
- On an annual basis, within 60 calendar days of the market authorization anniversary or a date agreed upon at the time of the issuance of the market authorization, status reports on the progress of ongoing confirmatory trials, as per section 3.2 and Appendix 4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). The details of the requirements for filing and termination of the annual status report as agreed upon by the Hoffmann-La Roche Limited and Health Canada must be outlined in the Letter of Undertaking.
- Report all serious Adverse Reactions (AR) that occur in Canada and all serious unexpected ARs that occur outside of Canada within 15 days to the Marketed Health Products Directorate. Adverse Events (AE) and AR reports on marketed drugs occurring as part of confirmatory trials subject to clinical trial applications, as outlined in the Letter of Undertaking, must be sent to the Biologics and Genetic Therapies Directorate. Reporting must be conducted as per section 3.4.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) and in accordance with current regulations and guidelines (e.g. Guidance for Industry: Reporting Adverse Reactions to Marketed Health Products and the Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
- Provide Periodic Safety Update Reports or Periodic Benefit-Risk Evaluation Reports-C for NOC/c Products (PSUR-Cs or PBRER-Cs) on an annual basis until such time as conditions associated with the market authorisation are removed. PSUR-Cs/PBRER-Cs should be prepared in accordance with the E2C(R1) and E3C(R2) ICH Guideline, including format and content, as per section 3.4.2 of the Guidance Document: Notice of Compliance with Conditions (NOC/c);
- Comply with the notification and reporting of specific issues of concern as outlined in Section 3.4.4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- Implement the Risk Management Plan (RMP) in Canada and provide any updates to the RMP whenever available.
- Receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to OCREVUS (ocrelizumab) authorized under the NOC/c policy as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- Provide an outline of the agreed-upon advertising, labelling or distribution requirements, including a commitment to file revised Product Monographs under the appropriate submission type as information is made available as per section 4.3 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- Provide an up-to-date, complete listing of ongoing additional clinical trials related to OCREVUS (ocrelizumab), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- Provide copies of any marketing authorizations for OCREVUS (ocrelizumab) from any other drug regulatory authority as per Section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidances on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to Guidance Document: Notice of Compliance with Conditions) to the outstanding information within 30 calendar days of the date of this letter.
Your response to the above should be submitted with a copy of this letter to the Office of Submissions and Intellectual Property. In order to facilitate and ensure proper processing of your response, please include a revised Submission Certificate, quoting the product name, assigned dossier ID, and control number of the original submission, and address your response to:
Director, Office of Submissions and Intellectual Property
Therapeutic Products Directorate
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario, K1A 0K9
Attention: Office of Regulatory Affairs
Biologics and Genetic Therapies Directorate
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