Memorandum of Understanding between the Health Products and Food Branch of the Department of Health of Canada and the Health Sciences Authority of Singapore

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The Health Products and Food Branch ("HPFB") of the Department of Health of Canada ("Health Canada") and the Health Sciences Authority of Singapore ("HSA"), hereinafter jointly referred to as "the Participants",

Have reached the following understanding:

1. Intention of Co-operation and Objectives

• 1.1 This Memorandum of Understanding ("MOU") is an arrangement between the Participants for the exchange of information in regards to Health Products. It is intended to advance and improve policy and operational regulatory affairs throughout the pre-market and post-market lifecycle of Health Products and enable the Participants to acquire reciprocal knowledge and understanding of each other's regulatory requirements and processes and to improve the safety, quality and efficacy of Health Products marketed in each country. This may be done by:
  1. enhancing the communication and collaboration between the two health regulatory organizations;
  2. establishing mechanisms for the sharing and exchange of documents and/or information relating to the review and evaluation of investigational and marketing applications, establishment compliance, or post-marketing surveillance; and
  3. encouraging the development of collaborative activities relating to the regulation of Health Products.
• 1.2 The Participants do not intend this MOU to create any legal obligations of any nature, either in domestic or international law.
• 1.3 This MOU will not modify existing cooperative activities nor will it preclude entering into separate arrangements for special programs that can be handled more efficiently and expeditiously by such arrangements.
• 1.4 This MOU is not intended to diminish or otherwise affect the authority of either Participant to carry out its regulatory responsibilities and programs. For greater certainty, provisions of this MOU are not intended to restrict either Participant from conducting its own inspection of a health product manufacturing facility within the jurisdictional boundaries of the other country when needed to meet the needs of its own regulatory programs.

2. Scope and Areas of Voluntary Co-operation

• 2.1 For purposes of this MOU, "Health Product(s)" will cover pharmaceutical products for human use (including finished dosage forms, radiopharmaceutical products and substances for use in these products); biological products for human use (for example, vaccines, including gene, cell, blood products); natural or traditional health products (for example, vitamins, minerals, herbal medicines and traditional Chinese medicines), and medical devices for human use.
• 2.2 This MOU will cover the following three broad areas of voluntary co-operation:
  1. Sharing and exchange of information;
  2. Development of professional competencies; and
  3. Scientific collaborations.
• 2.3 In the area of sharing and exchange of information, the Participants envision that the sharing and exchanging of information may include, but not be limited to, the following types of information:
  1. Guidance documents, policies, procedures, and other technical documents available to the Participant that are related to Health Products for which each Participant has responsibility.
  2. Information relating to the evaluation of marketing authorization applications respecting Health Products including the provision of assessment reports, and risk management reports in evaluation.
  3. Information related to enforcement activities, post marketing surveillance and product investigations respecting Health Products.
  4. Information contained in clinical trials or related to marketing or investigational applications for Health Products, among the various discipline reviews.
  5. Post-marketing data and information that could have an impact on the public health, such as pharmacovigilance data, investigation associated with adverse events arising from the use of Health Products or information about regulatory actions including proposed market withdrawals and product recalls.
  6. To the extent possible, information on quality defects or product recalls of Health Products known by the HPFB to have been manufactured or distributed in Singapore, and products known by HSA to have been manufactured or distributed in Canada.
  7. Information related to manufacturing compliance, distribution, wholesaling, testing or importing sites based on a good manufacturing practice (GMP) inspection of Health Products.
  8. Information on facilities registered or authorized in each Participant's country - that then market products to the other Participant's country - including facilities that only export their products.
  9. Information and cooperation on international harmonization activities relating to the regulation of Health Products.
  10. Information on technology (e.g. information systems, database systems, and other related computer applications) that support the evaluation/review of the safety, quality, and efficacy of Health Products.
  11. Information on activities of a Participant respecting Health Products that include public involvement, consultations or communication.
• 2.4 The Participants may develop specific procedures for co-operative and collaborative activities related to the training and development of professional competencies in the evaluation, assessment or regulation of specified Health Products. The collaborative activities may include the exchange of personnel, collaborative research relating to the quality, safety or efficacy of Health Products, and the planning of joint workshops, conferences, seminars or meetings.

3. Use of Confidential Information

• 3.1 Information shared or exchanged will not be used for purposes other than those set out in this MOU. Each Participant acknowledges that it will not use the confidential information for any purpose other than set out in this MOU.
• 3.2 Information exchanged under this MOU may include confidential information, that is exempt from public disclosure under the laws and regulation of Canada and Singapore including but not limited to trade secret information or personal information.
• 3.3 Each Participant acknowledges that confidential information which is exempt from public disclosure will only be shared with each other according to the procedures and policies of the parties as permitted by their respective laws.
• 3.4 Each Participant acknowledges that they will not share or disclose confidential information received from the other, whether in written, visual, electronic, oral or any other form, except with the express written consent of the owner of the information (for example, the manufacturer). When seeking such consent, each Participant acknowledges that it will inform the owner of the purposes for which the other Participant intends to use the information and confirm that the other Participant will treat the information as confidential in so far as it is not already lawfully in the public domain.
• 3.5 Unless otherwise required by applicable law to which the respective Participant is subject, each Participant will make all reasonable efforts to protect the confidentiality of the information that it receives from the other, from disclosure to third parties. Neither Participant will release confidential information to any other person other than their own employees, agents or contractors who need to know the information for work purposes in respect of this MOU and who are legally bound to protect the confidential nature of the information in the same or comparable ways as the Participants, except with the express written consent of the other Participant or written confirmation from the other Participant that the information is lawfully in the public domain.
• 3.6 Each Participant will inform the other, within two working days, of any effort made, pursuant to a judicial, legislative or other authority, to obtain confidential information that has been provided by one Participant to the other Participant. If disclosure is required pursuant to such authority, the other Participant will take all reasonable measure to ensure that the information will be disclosed in a manner that protects the information from any disclosure that is not authorized by the judicial or legislative or other authority.
• 3.7 Each Participant will promptly inform the other Participant of any changes to their respective laws or policies or procedures that may affect their treatment of confidential information obtained from the other Participant.

4. Funding of Initiatives/Programmes under the MOU

Each Participant will be responsible to fund and carry out its own activities under this MOU as it may wish.

5. Administration and Establishing the Steering Committee

• 5.1 The Participants will establish a joint Steering Committee chaired by the Assistant Deputy Minister of the HPFB of Health Canada and the Chief Executive Officer (CEO) of HSA or any senior officer appointed by the respective Chairpersons. The Steering Committee will comprise senior management and senior scientific staff of HPFB and coordinators for each Participant. The Steering Committee will set directions and priorities, including setting of a co-ordinated annual Work Plan for areas of co-operation; oversee the implementation of this MOU; and periodically review progress regarding this MOU.
• 5.2 The Steering Committee may form sub-committee(s) to ensure smooth and effective coordination or implementation of any plans, programs or activities. In addition to on-going communication via telephone, telephone-conferences, videoconferences or written correspondence, designated representatives of the Steering Committee will aim to meet once every year.
• 5.3 Each Participant will identify a coordinator responsible for the administration and monitoring of this MOU to implement the Work Plan on behalf of the Steering Committee and provide regular reports on progress against the Work Plan. For HPFB, the coordinator will be the Director of International Affairs, Policy, Planning and International Affairs Directorate (PPIAD), or authorized designate. For HSA, the coordinator will be the Deputy Director at the Office for Corporate Planning, or authorized designate.

6. Coming into Effect, Amendment and Termination

• 6.1 This MOU will come into effect on the day on which it is signed by both Participants and will remain in effect for ten years unless one of the Participants notifies the other in writing of its intention to terminate. Termination will take effect thirty (30) calendar days from the date on the written notice of the intention to terminate.
• 6.2 After the first year of implementation, the Participants should jointly review the MOU and make adjustments as necessary.
• 6.3 This MOU may be amended at any time with the written consent of the Participants. Any such amendment would come into effect on the date determined by the Participants.

Signed in duplicate at Ottawa, Canada, on this 20^th Day of September 2006, in the English and French languages, each version being equally valid.