Enregistrement :
36
de
64
(2018-02-12
à
2018-07-11)
Politique ou Programme
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Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions
Politique ou Programme, Règlement
Orphan Drug Regulatory Framework as it relates to separate regulatory pathway for drugs for rare diseases
Proposition législative, Projet de loi ou résolution
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
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