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Notice - Release of Proposed Revisions to Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

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March 27, 2009
Our file number: 09-108207-996

Release of Proposed Revisions to Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

Health Canada is pleased to announce the release of this revised version of its Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations.

The guidance document was developed in response to the amendments to the Food and Drug Regulations which came into force on October 5, 2006. The amendments were published in Canada Gazette, Part II on October 18, 2006 [SOR/2006-241]. The final version of the Guidance was released on March 24, 2009. These proposed additions reflect the administration of the data protection provisions in light of the Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) published concurrently with this notice.

It is proposed that the following paragraphs be inserted into the text of the Guidance at the sections identified:

• 3. Submissions comparing to Innovative Drugs

3.1 Prevention from filing of a submission on the basis of a direct or indirect comparison with an innovative drug

A submission for a subsequent entry biologic (SEB) as set out in the Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (SEB Guidance) comparing to an innovative drug will not be accepted for filing within the six-year period from the date of issuance of the NOC for that innovative drug.

As stated in the SEB Guidance, the concept of an SEB applies to biologic drug submissions in which a sponsor is seeking to reduce the clinical and non-clinical study requirements by establishing similarity to a previously authorized, innovative biologic reference product. The SEB submission relies, in part, on prior information regarding the previously approved innovative biologic drug in order to justify a reduced clinical and non-clinical package as part of the submission. Within the submission, the demonstration of similarity of the two drugs is based on comparative data generally including analytical and biological characterization, comparative pharmacokinetic and pharmacodynamic studies and comparative clinical trials.

For submissions in which a non-Canadian biologic reference product is substituted for the Canadian drug and is used as part of the demonstration of similarity to the drug marketed in Canada, the OPML will look for the required documentation that supports the substitution and links the foreign reference biologic product to the Canadian version of the reference biologic product. For the purposes of C.08.004.1, this is an indirect comparison and triggers the bar preventing the filing of such a submission within the six-year period from the date of issuance of the NOC for the innovative drug.

Comments on the proposed revisions should be provided to Health Canada, within 60 from the date of this notice.

The comments provided during the stakeholder consultation period may be disclosed publicly. Persons submitting comments should stipulate any parts of the comments that should not be disclosed pursuant to the Access to Information Act (in particular, pursuant to sections 19 and 20 of that Act), the reason why those parts should not be disclosed and the period during which they should remain undisclosed. Representations should also stipulate those parts of the comments for which there is consent to disclosure pursuant to the Access to Information Act.

Comments pertaining to this notice should be directed to:

Office of Patented Medicines and Liaison
Therapeutic Products Directorate
Finance Building
Address Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: (613) 941-7281
Fax: (613) 946-5610
E-mail: opml_bmbl@hc-sc.gc.ca or patent_register@hc-sc.gc.ca