Memorandum of Understanding Between Health Canada and the Standards Council of Canada

Memorandum of Understanding Pertaining To Good Laboratory Practice (GLP) Monitoring Authority Recognition

Between:

Health Canada - represented by the Assistant Deputy Minister, Health Products and Food Branch (on behalf of the Assistant Deputy Ministers for the Health Products and Food Branch and the Pest Management Regulatory Agency of Health Canada), hereinafter referred to as Health Canada

And:

The Standards Council of Canada - represented by the Vice President, Accreditation Services, hereinafter referred to as SCC

("The Participants")

WHEREAS:

1. Health Canada is the Canadian federal department responsible for matters relating to the promotion and preservation of the health of the people of Canada, including helping protect the people of Canada against risks to health and, in the case of pest control products, risks to the environment. Health Canada also works closely with other federal departments, agencies and health stakeholders to reduce health and safety risks to Canadians.
2. The Health Products and Food Branch of Health Canada, on behalf of the Minister of Health, administers the Food and Drugs Act (FDA) and its regulations, which applies to all food, drugs, natural health products, cosmetics and medical devices sold in Canada, whether manufactured in Canada or imported. The FDA and Regulations govern the sale and advertisement of these products to help ensure their safety and prevent deception. The FDA and its regulations also set out the labelling requirements for food. The mandate of HPFB is to minimize health risk factors to Canadians while maximizing safety through the regulatory system for health products and food.
3. The Pest Management Regulatory Agency (PMRA) of Health Canada, on behalf of the Minister of Health, administers the Pest Control Products Act (PCPA) and its regulations, including all aspects of human health and environmental risk and value assessments, regulatory decisions regarding pest control products and compliance with the PCPA.
4. The Standards Council of Canada (SCC) is a federal Crown corporation. The SCC takes its mandate from the Standards Council of Canada Act, its governing legislation. The mandate of the SCC is to promote efficient and effective voluntary standardization in Canada, where standardization is not expressly provided for by law and, in particular, to
   • promote the participation of Canadians in voluntary standards activities,
   • promote public-private sector cooperation in relation to voluntary standardization in Canada,
   • coordinate and oversee the efforts of the persons and organizations involved in the National Standards System,
   • foster quality, performance and technological innovation in Canadian goods and services through standards-related activities, and
   • develop standards-related strategies and long-term objectives, in order to advance the national economy, support sustainable development, benefit the health, safety and welfare of workers and the public, assist and protect consumers, facilitate domestic and international trade and further international cooperation in relation to standardization;
5. Canada is a Member country of the Organization for Economic Co-operation and Development ("OECD") and as a Member country of the OECD, wishes to conform to:
   • The OECD Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals, 12 May 1981 - [C(81)30/Final], amended on 26 November 1997 - [C(97)186/Final] ("OECD Decision") with its Test Guidelines ("OECD Test Guidelines") and Principles of Good Laboratory Practice ("OECD GLP Principles"); and
   • The OECD Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice, 2 October 1989, [C(89)87/Final] ("OECD Decision Recommendation") with its Revised Guides for Compliance Monitoring Procedures for GLP, the Revised Guidance for the Conduct of Laboratory Inspections and Study Audits and the Guidance for the Preparation of GLP Inspection Reports;
6. The purpose of the OECD Principles of Good Laboratory Practice is to promote the development of quality non-clinical test data.
7. Part I of the 1989 OECD Decision-Recommendation requires a Member country, in which the testing of chemicals for purposes of assessment related to the protection of health and the environment is being carried out pursuant to the principles of good laboratory practice that are consistent with the OECD GLP Principles, to establish national procedures for monitoring compliance with OECD GLP Principles based on laboratory inspections and study audits, and designate an authority to discharge the functions required by the procedures for monitoring compliance to the Principles;
8. Part II of the 1989 OECD Decision-Recommendation requires a Member country to recognize the assurance by another Member country that test data have been generated in accordance with GLP Principles if such other Member country complies with this Part and Part I of the Decision-Recommendation;
9. Health Canada recognizes the importance of the SCC's role as the Monitoring Authority in their GLP Compliance Program, and has done so for pest control products since 1998, and for pharmaceuticals, radiopharmaceuticals and biologic drugs since 2010;
10. The SCC has knowledge and extensive experience in the implementation of the OECD GLP Principles and OECD Guidance Documents for Compliance Monitoring Authorities;
11. The SCC is presently the sole OECD-recognized GLP Monitoring Authority in Canada.

The Participants concur as follows:

1.0 Definitions

In this Memorandum of Understanding (MOU):

• Drug includes any substance or mixture of substances manufactured, sold or represented for use in
  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
  2. restoring, correcting or modifying organic functions in human beings or animals, or
  3. disinfection in premises in which food is manufactured, prepared or kept.
• GLP is a quality system covering the organizational process and conditions under which non-clinical human health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. It is intended to promote the quality, validity and international acceptability of non-clinical health and environmental safety studies.
• Official languages means French and English.
• Pest control product means
  1. a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;
  2. an active ingredient that is used to manufacture anything described in paragraph (a); or
  3. any other thing that is prescribed to be a pest control product
• Program means SCC's GLP Recognition Program as described in the current version of SCC's document - Accreditation Program Overview.

The following terms shall be defined and have the same meaning as in the OECD Principles of GLP and Guidance Documents for Compliance Monitoring Authorities:

1. "GLP Principles";
2. "GLP Compliance Monitoring";
3. "(National) GLP Compliance Programme";
4. "(National) GLP Monitoring Authority;
5. "Test Facility Inspection";
6. "Inspector"
7. "Study Audit";
8. "GLP Compliance Status"; and
9. "Regulatory Authority".

2.0 Purpose:

2.1 The purpose of this MOU is to outline the concurrence of the Participants as it pertains to:

• 2.1.1 HPFB's data integrity requirements (ie: Guidance Document, entitled "Non-Clinical Laboratory Study data supporting Clinical Trial Applications and New Drug Submissions; Adherence to Good Laboratory Practices (GLP)", requiring OECD Principles of Good Laboratory Practice be followed) for test results submitted by Canadian facilities involved in the non-clinical safety testing of drugs;
• 2.1.2 PMRA requires, under authority of the PCPA, that applications for registration be accompanied by scientific information that will allow the PMRA to determine whether the risks to human health and the environment, and the value of the pest control product are acceptable. Further, in accordance with Regulation Directive 98-01, human health and environmental safety related studies are to be conducted in accordance with GLP principles to support data quality; and
• 2.1.3 Health Canada's recognition of the SCC as an official OECD- approved GLP monitoring authority with regard to said facility's compliance to the GLP Principles within the SCC's existing compliance Program framework.

2.2 This MOU is not intended to create legally binding obligations between the Participants either under domestic or international law.

3.0 Roles of the Participants

Role of the SCC

3.1 The SCC will act as the GLP Compliance Monitoring Authority for Canadian facilities involved in the non-clinical safety testing of drugs and pre-market testing of pest control products. In this role, the SCC will:

• Administer a GLP compliance monitoring program in accordance with the OECD Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice, Environment Monograph No. 110 (Paris 1995) or subsequent versions;
• Adhere to compliance monitoring program procedures jointly developed by both Participants and described in the current version of SCC's document - Accreditation Program Overview, and consult with the Health Canada before modifying these requirements; and
• Be represented at scheduled meetings of the OECD GLP Working Group.

Role of Health Canada

3.2 Health Canada will act as the Regulatory Authority for Canadian GLP- compliant studies on the non-clinical safety testing of drugs and pre-market testing of pest control products. In this role, Health Canada will:

• 3.2.1 Accept as sufficient proof of GLP compliance, the fact that a study was conducted in a facility recognized by the SCC GLP Compliance Monitoring Authority; and
• 3.2.2 Maintain an official personnel point of contact for SCC, in order to facilitate the dissemination of GLP program bulletins and updates from SCC to expert staff within Health Canada in a timely and efficient manner.

4.0 Recognition of Compliant Test Data

4.1 SCC administers a GLP compliance program for studies (ie: "GLP RecognitionProgram") which designates GLP criteria.

4.2 The successful compliance is evidenced as a "GLP certificate of recognition".

4.3 The "GLP certificate of recognition" will be recognized by Health Canada that the test data has been generated in accordance to GLP Principles and is acceptable for data submission in order to authorize the eventual marketing of the drug or pest control product in Canada.

5.0 Official Languages

5.1 Program recognition: The GLP letters of recognition will be printed in both official languages.

5.2 Program materials: All Program documentation, requirements and information will be printed in both official languages.

6.0 Accessibility

6.1 The Program is accessible and transparent to all testing facilities within Canada.

6.2 The Program is accessible and transparent to all levels of Government: Municipal, Provincial, and Federal.

6.3 The Program is accessible and transparent to the public.

7.0 Revision and Review of the Program

7.1 SCC may change the content of standards, test protocols, terms of reference and or other parts of the Program. Health Canada will be advised, in writing, of any changes brought forward within ten (10) working days of their inception.

7.2 It is anticipated that the Program will be reviewed in five-year intervals by Health Canada, and that the results will be shared with SCC.

8.0 Reporting

8.1 SCC will share annual reports with Health Canada outlining the results achieved, including the following:

• degree of domestic testing facility participation in the Program (if known);
• aggregate summaries of the removal or correction of non-compliant studies;
• any special problems or opportunities that may have a significant impact on the Program;
• the number of testing facilities newly listed or delisted from the Program; and
• any other matter or results that may affect public safety with respect to the product governed by the Program.

9.0 Notice

9.1 Wherever in this MOU a notice is to be given by one Participant to the other Participant, such notice will be in writing and will be validly given or sufficiently communicated as follows:

The addresses for delivery are:

For SCC:

Standards Council of Canada
c/o Director, Accreditation Services
600-55 Metcalfe
Ottawa, ON, KIP 6L5

For Health Canada:

Assistant Deputy Minister's Office
c/o Assistant Deputy Minister, Health Products and Food Branch
AL 2005C, 250 Lanark Avenue
Ottawa, ON, K1A 0K9
And;

Executive Director's Office
Pest Management Regulatory Agency
2720 Riverside Drive
Ottawa, ON, K1A 0K9

10.0 Duration and Withdrawal

10.1 The Participants intend to jointly review this MOU every five (5) years and make any necessary adjustments.

10.2 This MOU may be amended or terminated at any time upon written mutual consent of the Participants.

10.3 Either Participant may terminate this MOU in writing at any time, with sixty (60) days written notice to the other Participant.

10.4 This MOU will be automatically renewed post the completion of the initial term as defined in clause 10.1, for periods of two (2) years, unless written notice received from on participant to the other participant.

FOR HEALTH CANADA

HEALTH PRODUCTS AND FOODS BRANCH:

By: Mr. Pierre Sabourin
Title: Assistant Deputy Minister, HPFB
Signed this 6^th day of May, 2019

PEST MANAGEMENT REGULATORY AGENCY:

By: Mr. Richard Aucoin
Title: Executive director, PMRA
Signed this 15^th day of May, 2019

FOR STANDARDS COUNCIL OF CANADA

By: Mr. Elias Rafoul
Title: Vice President, Accredited Services, SCC
Signed this 3^rd day of June, 2019