Legislative Proposal, Bill or Resolution

• Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry
• Patent Act as it relates to further changes affecting patent term restoration
• User Fees Act with respect to cost recovery

Legislative Proposal, Bill or Resolution, Policies or Program

• Food and Drugs Act as it relates to modernization,Protecting Canadians From Unsafe Drugs Act (as it relates to the release of confidential business information)

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
• Guidance for Industry: Issuance of Health Professional Communications and Public Communications by Market Authorization Holders and Draft Guidance Document: Triggers for Issuance of Risk Communication Documents for Marketed Health Products for Human Use with respect to communications from manufacturers, health professionals and consumers, to the public via Health Canada and manufacturers, and Product Monographs
• Health Canada International Memorandum of Understanding with respect to exchanging data and safety protocols
• Health Canada Post Notice of Compliance Change Guidance: Quality with respect to the categorization of a change and the recommended supporting data for any changes to the Quality information associated with a new drug
• Implementation of the National Pharmaceutical Strategy as it affects the industry; "National Pharmacare/ universal drug coverage"
• Pandemic Planning as it relates to the Task Group on Antiviral Prophylaxis recommendations
• Patent Act as it relates to changes to Canada's Access to Medicines Regime
• Patented Medicine Prices Review Board in respect of proposed Pricing Guidelines
• Progressive Licensing Framework with respect to its development and government consultations
• Science and Technology Strategy as it relates to new policies for the pharmaceutical industry
• Therapeutic Products Directorate's work as it relates the Guidance for Industry: Management of Drug Submissions with respect to the review and approval of submissions

Policies or Program, Regulation

• Creation of pathways for Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors: Information and Submission Requirements for SEBs, regulations and intellectual property policies
• Orphan Drug Regulatory Framework as it relates to separate regulatory pathway for drugs for rare diseases

Regulation

• Amendments to the Food and Drugs Act Regulations as it relates to further changes to data protection
• Data Protection Regulations with respect to its implementation and application to the Food and Drugs Act
• Patent Act as it relates to Patented Medicines (Notice of Compliance) Regulations and possible changes to modernize and Right of Appeal