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Notice - Release of Proposed Additions to Guidance Document: Patented Medicines (Notice of Compliance) Regulations

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

Release of Proposed Additions to Guidance Document: Patented Medicines (Notice of Compliance) Regulations

Health Canada is pleased to announce the release of proposed additions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations for stakeholder consultation.

The Guidance outlines the roles and responsibilities of first persons, second persons and the Therapeutic Products Directorate under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The additions reflect the Therapeutic Products Directorate's administration of the PM(NOC) Regulations in light of the revised Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) published concurrently with this notice.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:

• 2 Definitions
  
  Subsequent Entry Biologic: This term is defined as in Health Canada's Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs).
  
  
• 3.4.1 Scope and Application of Section 5
  
  Subsequent Entry Biologics
  As noted above, the language of section 5 of the PM(NOC) Regulations is not exclusive to abbreviated new drug submissions. Rather, it is meant to capture submissions approved on the basis of a direct or indirect comparison or reference. As such, new drug submissions submitted in accordance with the Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (SEB Guidance) that establish similarity with an innovative biologic product previously authorized and marketed in Canada and listed on the Patent Register, are considered second persons for the purpose of subsections 5(1) and 5(2). Sponsors of such submissions will be required to fulfill the requirements for second persons under the PM(NOC) Regulations.
  
  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.
  
  In accordance with the SEB Guidance, a sponsor of an SEB submission may use a non-Canadian reference biologic product as part of the demonstration of similarity between the SEB and the reference biologic product. As prescribed, a link must be established in the new drug submission between the non-Canadian reference product and the drug authorised in Canada. As such, these submissions are considered to contain a comparison or reference to drug for the purpose of section 5 of the PM(NOC) Regulations. Where the Canadian drug is found on the Patent Register, the SEB sponsor will be considered a second person and must comply with section 5.
  
  
• 3.5.1 Scope and Application of Section 5
  
  In determining that there has been a comparison or reference to a drug for the purpose of subsection 5(1) or 5(2) of the PM(NOC) Regulations, the OPML will refer to the drug submission. As set out in 3.4.1, the OPML will look for the demonstration of similarity to another drug found on the Patent Register which is established on the basis of comparative data including analytical and biological characterization, comparative pharmacokinetic and pharmacodynamic studies and comparative clinical trials.
  
  Where comparative data is found and it is determined that a direct or indirect comparison is made with a biologic reference product authorised in Canada and that reference product is found on the Patent Register, the second person must comply with section 5.
  
  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 reference biologic product. The OPML will consider this a comparison or reference to the Canadian drug. Where the Canadian drug is listed on the Patent Register, the second person will be required to comply with section 5 of the PM(NOC) Regulations.
  
  Refer to section 3.4 for further information.

Comments on the proposed updates should be provided to Health Canada, within 60 days 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 should be directed to:

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

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