Ipsen Biopharmaceuticals Canada Inc.
Registration:
3
of
7
(2020-09-30
to
2021-02-16)
Legislative Proposal, Bill or Resolution
- Food and Drugs Act Modernization initiative, including the Regulatory Review of Drugs and Devices.
- 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 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.
- Patent Act and Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property and approval for therapeutic products.
Policies or Program
- Common Drug Review and the pan-Canadian Oncology Drug Review, as they relate to health technology assessments and drug product reimbursement recommendations.
- Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries.
- 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 in Canada.
- National Pharmacare policies and programs, including the Canadian Drug Agency Transition office, and a national rare disease strategy.
- National Pharmaceuticals Strategy, as it relates to enhanced access to orphan drugs and incentives for development of the treatments for rare disorders.
- Proposals to modernize the operations of the Patented Medicine Prices Review Board (PMPRB), including guidelines development.
Policies or Program, Regulation
- Regulations regarding the exportation of medicines packaged and labelled for the Canadian market to countries other than Canada.
Regulation
- Amendments to the Patented Medicines Regulations published in Canada Gazette, Part II on August 21, 2019 and June 10, 2020.