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Addressing Enabling Conditions

Objectives

  • To strengthen the regulatory capacity of developing national regulatory authorities (NRAs) targeted on vaccine and clinical trial application submissions, including those related to HIV/AIDS;
  • To support the integration of ethical review in vaccine and clinical trial regulation development occurring in low-and-middle-income countries;
  • To implement the harmonization of regulatory standards and policies related to the vaccine approval and clinical trial regulatory process;
  • To promote the adaptation and exchange of domestic and international best practices and protocols in health policy approaches; and
  • To strengthen existing mechanisms to support community involvement in vaccine research, clinical trials and activities related to public awareness and education.

Activities

  • Support activities that strengthen Canada's contribution to global HIV vaccines-related policy development and domestic community-engagement efforts;
  • Support to the WHO for capacity-building activities intended to improve regulatory capacity in low-to-middle income countries, especially in countries where clinical trials are planned or are ongoing;
  • Support for Health Canada's International Regulatory Forum held annually, designed to reflect the most common and relevant areas of interest to developing NRAs. Support would allow for expanded training, to address the needs of developing NRAs involved in HIV/AIDS clinical trial applications;
  • Capacity Building Mentoring/Training Programs for African NRAs, including bi-lateral and multi-lateral sessions held in person within Canada and in low-and-middle-income countries, would address challenges identified by the developing NRA in consultation with WHO-African Vaccines Regulatory Forum (AVAREF);
  • An on-line resource community developed in consultation with WHO-AVAREF for training information, including a communication platform that will enable regulatory authorities, ethics committees and the Pan African Clinical Trials Registry to share information about clinical trials;
  • Providing guidance to sponsors of HIV vaccine clinical trials in meeting the regulatory requirements of a targeted country; and
  • Global Regulatory Workshop for HIV Vaccines to assess critical roadblocks in global regulatory pathways and develop collaborative solutions including, but not limited to, new models, protocols, concept papers and policy papers.

Outcomes

  • Within low-and-middle-income countries create a regulatory capacity sufficient to protect vulnerable human research subjects in HIV vaccine clinical trials;
  • Within low-and-middle-income countries contribute to ensuring that trials with HIV vaccines are performed in accordance with the internationally accepted principles of Good Clinical Practices. This will help ensure that data generated with HIV vaccine clinical trials conducted in low-and-middle-income countries will be accepted by regulators worldwide, including Canada;
  • Promote the harmonization and exchange of domestic and international best practices and protocols related to heath policy and the regulation of vaccines and clinical trials to the benefit of Canada and other countries; and
  • Meaningful engagement of Canadian communities in all aspects of the HIV vaccine research and development continuum.