ARCHIVED - Notice

Contact:

• Therapeutic Products Directorate
• Biologics and Genetic Therapies Directorate

January 3, 2006

Our file number: 05-128882-531

Release of Final Guidance Document and Revisions to Six Guidances and Policies

Final guidance document: Reconsideration of Final Decisions Issued for Human Drug Submissions

The final version of the Health Canada guidance document Reconsideration of Final Decisions Issued for Human Drug Submissions is now available. This guidance document is a revised version of the draft published for consultation in February 2005, of the same title. The final guidance document outlines the process for industry and staff regarding requests for reconsideration of final decisions and replaces the Health Canada policy: Appeals Procedures for Drug Submissions.

Comments received from the consultation on the draft version of the guidance document were reviewed and considered in the finalization of this document. Detailed comments and Health Canada discussion and response are outlined in the attached document, entitled Summarised Comments and Recommendations from External Consultations.

Should you have any questions regarding the content of the guidance document, please contact:

Office of Science Policy - Bureau Therapeutic Products Directorate
Holland Cross, Tower B, A.L. 3102C3
1600 Scott Street
Ottawa, ON K1A 0K9
Tel: (613) 948-4623
Fax: (613) 941-1812
E-mail: Policy Bureau Enquiries

Office of Quality and Risk Management Biologics and Genetic Therapies Directorate
Building #7
Tunney's Pasture, A.L. 0702E
Ottawa, ON K1A 0K9
Tel: (613) 946-5434
Fax: (613) 946-5214
E-mail: BGTD DGO Enquiries

Effective Date and Transition Period

The final guidance document Reconsideration of Final Decisions Issued for Human Drug Submissions is effective as of March 1, 2006, and will apply to all final decisions issued after that date. As of March 1, 2006, the Appeals Procedures for Drug Submissions Policy will no longer be in effect and will be removed from the Health Canada website.

In the interim, for decisions issued between January 1, 2006 and February 28, 2006, sponsors may choose which process to follow. For an eligible decision issued after January 1, 2006, a sponsor may either file a level 1 appeal in accordance with the Appeals Procedures for Drug Submissions Policy, or file a Request for Reconsideration in accordance with the guidance Reconsideration of Final Decisions Issued for Human Drug Submissions. Sponsors may not file both an appeal and a Request for Reconsideration for the same decision. The Letter of Intent filed should clearly indicate which process the sponsor is choosing to follow.

Level 1 and level 2 appeals filed for decisions issued prior to January 1, 2006 will proceed to their conclusion as filed.

Revisions to six Health Canada guidances and policies

Posted for consultation with the above-referenced draft guidance document was a revised draft Guidance for Industry: Management of Drug Submissions. The proposed revisions were intended to improve the prevention and early identification and resolution of disputes within the drug submission process, without compromising the safety, efficacy, or quality of regulated products.

The Management of Drug Submissions Guidance has also been revised to be consistent with the Health Canada Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names. In addition, the document has been revised to reflect current organizational structure and addresses.

The revised version of the Management of Drug Submissions Guidance is now available on the Health Canada website and is effective immediately.

Changes were necessary to the following Health Canada documents as a result of the finalization of the guidance document Reconsideration of Final Decisions Issued for Human Drug Submissions:

• Policy: Priority Review of Drug Submissions
• Guidance for Industry: Priority Review of Drug Submissions
• Policy: Notice of Compliance with Conditions
• Guidance for Industry: Notice of Compliance with Conditions
• Policy: Drug/Medical Device Combination Products

The revised versions of these policies and guidance documents are now available on the Health Canada website and are effective as of March 1, 2006.

Questions related to these six policies and guidance documents should be directed to their individual contacts, identified for each document on the Health Canada website.