Monitoring and engagement on federal roles in health system planning and preparedness as they relate to blood?related products and plasma?derived medicines used in federally funded programmes and public health responses. Engagement on federal policies and programmes related to the availability, appropriate use, and continuity of supply of plasma?derived therapies, including immunoglobulins, for patients with immune?mediated and rare conditions. Health Canada regulatory modernisation initiatives, including regulatory innovation, flexibility, predictability, and alignment with international approaches. Innovation, Science and Economic Development Canada initiatives and programmes supporting life sciences research, development, and advanced therapies conducted in Canada. Federally funded public drug plans, including programmes for Indigenous Peoples, veterans, and federal plan beneficiaries, with respect to reimbursement of therapeutic products. Engagement on international trade discussions and policies that may impact access to medicines and the security of drug supply in Canada. Monitoring and engagement on legislation, regulations, and policies related to national pharmacare, including implementation of relevant federal Acts. Monitoring and engagement on the Government of Canadas National Strategy for Rare Diseases, including related policy frameworks and implementation considerations. Health Canada policies and guidance related to the prevention, monitoring, and management of drug shortages. Regulatory frameworks related to the Patented Medicines (Notice of Compliance) Regulations as they apply to the protection of intellectual property for innovative medicines. Pharmaceutical pricing policy considerations within the mandate of the Patented Medicine Prices Review Board (PMPRB), including regulatory amendments and associated guidance. Engagement on federal policies and frameworks that support improved coordination across jurisdictions to facilitate timely patient access following Health Canada approval. Canadas Drug Agency policy frameworks and processes related to reimbursement recommendations, including decision?making approaches and timelines. Policies and programmes related to Canadas Biomanufacturing and Life Sciences Strategy, including support for research, innovation, and manufacturing capability in Canada. Engagement on federal budget priorities and updates affecting the biopharmaceutical sector, including implications for patient access to innovative medicines, vaccines, and therapies.
Issues related to U.S. pharmaceutical importation, trade and policies, including research and development, regulatory authorizations, funding of medicines, supply sources and supply chains. Innovation, Science and Economic Development Canada and Innovation Agenda, Science and Technology Strategy, or other Government policy or program initiatives to support research and development activities and attract investments in Canada, including the Biomanufacturing and Life Sciences Strategy. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board Federally-funded Public Drug Plans, with respect to reimbursement for medicines for federal plan beneficiaries. Enhancement to Canada's regulatory and funding environment for new medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions. Enhancements related to intellectual property legislation, regulations and policies applicable to pharmaceuticals. Implementation of the National Strategy for Drugs for Rare Diseases and the Pharmacare Act.