Notice - Electronic Templates for the Quality Information of Drug Submissions for Biological Products and Radiopharmaceuticals

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Notice - Electronic Templates for the Quality Information of Drug Submissions for Biological Products and Radiopharmaceuticals (PDF Version, 41 Kb)
Date: 2004-08-31

September 1, 2004

Our file number:04-116818-698

As part of the Health Products and Food Branch's decision to accept drug submission documentation in Microsoft Word, the Biologics and Genetic Therapies Directorate is pleased to announce the availability of the following blank, electronic templates in Microsoft Word:

• Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D Drugs)) Template in the CTD Format
• Quality Information Summary- Biologicals (QIS-B) Templates
• Certified Product Information Document- Biologicals (CPID-B) Template
• Quality Information Summary- Radiopharmaceuticals (QIS-R) Template
• Certified Product Information Document- Radiopharmaceuticals (CPID-R) Template

These templates are found on the BGTD website.

Please note that some of these templates have undergone minor administrative-type revisions in order to keep them current with respect to organization name changes, website links, and to ensure consistent use of french terminology. Consequently, sponsors are encouraged to use the template versions currently available on the BGTD website, either in Wordperfect or Microsoft Word. However, since neither the content of these documents, nor the information requirements are affected by these changes, sponsors may continue to use the original WordPerfect version, if necessary.

As a reminder, sponsors are encouraged to use the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Common Technical Document format for newly filed drug submissions for human use, including the appropriate CTD formatted template (e.g. CPID (Schedule D Drugs)). While the ongoing use of Health Canada Quality templates (e.g., QIS-B, CPID-B, QIS-R, CPID-R) is still currently accepted, it is anticipated that these template versions will be phased-out eventually and only the CTD format will be used in Canada.

Questions or comments regarding the content of the notice, should be submitted to:

Biologics and Radiopharmaceuticals Evaluation Centre
Biologics and Genetic Therapies Directorate
Fax: (613) 948-3655
e-mail: CERB_s@hc-sc.gc.ca

Questions concerning general drug submission filing requirements should be directed to:

Submission Management Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
Fax: (613) 957-0364
e-mail: CERB_s@hc-sc.gc.ca