Hoffmann-La Roche Limited
Registration:
49
of
65
(2020-10-13
to
2021-01-08)
Grant, Contribution or Other Financial Benefit
- Strategic Innovation Fund, as it relates to any initiative submitted or supported.
Legislative Proposal, Bill or Resolution
- Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection
- Food and Drugs Act Modernization initiative as it relates to reform of drug submission review and approval process
- Food and Drugs Act and Regulations, as they relate to drug export and cross-border trade
- Food and Drugs Act and Regulations, as they relate to the establishment of an approval framework for subsequent entry biologic products
- Food and Drugs Act and Regulations, as they relate to the provision of data exclusivity for innovative drug products
- Food and Drugs Act and Regulations, as they relate to the review and approval of new drug submissions and post market surveillance of drug products
- House of Commons Standing Committee of Health's (HESA) as it relates to Pharmacare, rare disease and/or any other pertinent legislative proposal before the committee
- Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal
- Patent Act as it relates to changes affecting term restoration or Canada's Access to Medicines Regime
- Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution
- United States, Mexico, Canada Agreement (USMCA) and pharmaceutical intellectual property protection.
Policies or Program
- Biologics and Genetic Therapies Directorate as it relates to policies affecting the review and approval of submissions
- Clinical Trials environment in Canada: operational issues, investment, enrollment
- Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry
- Innovation Agenda - as it relates to the Life Science Industry and the Federal Initiative lead by Innovation, Science, Economic Development
- National Pharmaceutical Strategy and negotiation of the Health Accord, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing.
- Pandemic Planning as it relates to the Task Group on Antiviral Prophylaxis recommendations
- Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions
- Policies related to rare disease as it relates to separate regulatory pathway for drugs for rare diseases and government strategies.
- Policies related to the importation of pharmaceuticals from Canada to the United States
Policies or Program, Regulation
- Orphan Drug Regulatory Framework as it relates to separate regulatory pathway for drugs for rare diseases
Regulation
- Health Canada/PMPRB proposed regulation changes to the Patented Medicines Regulations.