Clarify the administration of Scientific Research & Experimental Development (SR&ED) program to ensure clinical trials and international research conducted in Canada qualifies as eligible expenses SUBMISSION REVIEW PROCESS FOR BIOLOGICS, COST RECOVERY REVIEW to ensure Canada remains competitive overall and any new costs do not put biologics at a comparative disadvantage REGULATORY APPROVAL PROCESS FOR PLANTS WITH NOVEL TRAITS as NOVEL FOODS or INDUSTRIAL BIO-PRODUCTS in respect of an efficient science-based approach and allows for greater cooperation among and between government departments INTELLECTUAL PROPERTY/PATENT POLICY AND REGULATIONS in respect of creating Canada as one of the world's most competitive jurisdictions in protecting IP (e.g., match level of European Union via the Comprehensive Economic and Trade Agreement negotiations) BIOSAFETY PROTOCOL in respect of Canada's participation in global discussions to ensure an enabling environment for safe new technologies ACCESS & BENEFIT SHARING: TRIPS AGREEMENT in respect of protecting intellectual property and preventing increased uncertainty Vaccine Funding - National Immunization Strategy - maintain federal leadership in providing provinces with funding for new vaccines VACCINE CONTRACTING AND SUPPLY to support the implementation of the federal biomanufacturing strategy, regulation of vaccines for Canadians, address immunization gaps, provide updated and timely information about vaccine development pipeline, support procurement of vaccines RESEARCH & DEVELOPMENT (R&D) to ensure Canadian capacity in key sectors including biomanufacturing, life sciences, and biotechnology. Policy measures to ensure security of drug supply in Canada and preserve Canada's attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations. PATENTED MEDECINES PRICES REVIEW BOARD (PMPRB) PRICE REVIEW to ensure new guidelines and directives do not create disincentives for the introduction of new treatments in Canada ORPHAN PRODUCTS to establish formal regulations, policies or programs to encourage the research, development and introduction of new technologies to treat "orphan" or neglected diseases NOVEL FOODS in respect of maintaining a science-based regulatory system for novel foods derived from plant and animal biotechnology IMPROVEMENTS TO THE Scientific Research & Experimental Development TAX CREDITS Free trade agreements as they relate to the biopharmaceutical industry. FOOD LABELLING in respect of mitigating the unnecessary introduction of new labelling requirements for products already approved under current regulated process and in respect of maintaining harmonization of requirements with trading nations FOOD AND DRUGS ACT AND REGULATIONS in respect of streamlining regulatory burden and ensuring appropriate climate for the introduction of new technologies Establish accountability with the federally established Canadian Drug Agency (formerly Canadian Agency for Drugs and Technologies and Health) (CADTH) and its Common Drug Review process (Health Canada) Creation of a modern policy environment that recognizes international standards and reviews, and establishes clarity on data ownership for intellectual property Canadian Government investments as they relate to the biopharmaceutical industry. CANADIAN ENVIRONMENTAL PROTECTION ACT AND REGULATIONS in respect of modern, science-based regulations to reflect rapidly changing new technologies Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry. ADVENTITIOUS PRESENCE POLICY in respect of new agricultural biotechnology products
Canadian Government investments as they relate to the biopharmaceutical industry. Policy measures to ensure security of drug supply in Canada and preserve Canada's attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations. Free trade agreements as they relate to the biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry. Vaccine Funding - National Immunization Strategy - maintain federal leadership in providing provinces with funding for new vaccines VACCINE CONTRACTING AND SUPPLY to support the implementation of the federal biomanufacturing strategy, regulation of vaccines for Canadians, address immunization gaps, provide updated and timely information about vaccine development pipeline, support procurement of vaccines SUBMISSION REVIEW PROCESS FOR BIOLOGICS, COST RECOVERY REVIEW to ensure Canada remains competitive overall and any new costs do not put bioloigics are a comparative disadvantage RESEARCH & DEVELOPMENT (R&D) to ensure Canadian capacity in key sectors including biomanufacturing, life sciences, and biotechnology. REGULATORY APPROVAL PROCESS FOR PLANTS WITH NOVEL TRAITS as NOVEL FOODS or INDUSTRIAL BIO_PRODUCTS in respect of an efficient science-based approach and allows for greater cooperation among and between government departments PATENTED MEDECINES PRICES REVIEW BOARD (PMPRB) PRICE REVIEW to ensure new guidelines and directives do not create disincentives for the introduction of new treatments in Canada ORPHAN PRODUCTS to establish formal regulations, policies or programs to encourage the research, development and introduction of new technologies to treat "orphan" or neglected diseases NOVEL FOODS in respect of maintaining a science-based regulatory system for novel foods derived from plant and animal biotechnology INTELLECTUAL PROPERTY/PATENT POLICY AND REGULATIONS in respect of creating Canada as one of the world's most competitive jurisdictions in protecting IP (e.g., match level of European Union via CETA negotiations) IMPROVEMENTS TO THE Scientifc Research & Experimental Development TAX CREDITS FOOD LABELLING in respect of mitigating the unnecessary introduction of new labelling requirements for products already approved under current regulated process and in respect of maintaining harmonization of requirements with trading nations FOOD AND DRUGS ACT AND REGULATIONS in respect of streamlining regulatory burden and ensuring appropriate climate for the introduction of new technologies Establish accountability with the federally established Canadian Drug Agency (formerly Canadian Agency for Drugs and Technologies and Health) (CADTH) and its Common Drug Review process (Health Canada) Creation of a modern policy environment that recognizes international standards and reviews, and establishes clarity on data ownership for intellectual property Clarify the administration of SR&ED program to ensure clinical trials and international research conducted in Canada qualifies as eligible expenses CANADIAN ENVIRONMENTAL PROTECTION ACT AND REGULATIONS in respect of modern, science-based regulations to reflect rapidly changing new technologies BIOSAFETY PROTOCOL in respect of Canada's participation in global discussions to ensure an enabling environment for safe new technologies ADVENTITIOUS PRESCENCE POLICY in respect of new agricultural biotechnology products ACCESS & BENEFIT SHARING: TRIPS AGREEMENT in respect of protecting intellectual property and preventing increased uncertainty