Novartis Pharmaceuticals Canada Inc.
Registration:
18
of
38
(2017-03-21
to
2017-05-01)
Legislative Proposal, Bill or Resolution
- Food and Drugs Act & Regulations as it relates to Drug Export restriction and cross border trade.
Legislative Proposal, Bill or Resolution, Regulation
- CETA implementation - Novartis is working through our Industry association, Innovative Medicines Canada (IMC) on the implementation of this trade agreement
Policies or Program
- Canada's orphan drug framework as it relates to reimubursement recommendations in Canada, and also in regards to the alingment of the framework with processess that are already implemented in the US and EU.
- Canadian Agency for Drugs and Technologies in Health (CADTH), including Therapeutic Reviews and the Common Drug Review as it relates to reimbursement recommendations for decision-making process and framework.
- Federal Innovation agenda. Working with our Industry Associations (Innovative Medicines Canada and BIOTECanada) to ensure that innovative medicines, and our contribution to Research and Development in Canada are part of the consultation process in the development of this new innovation agenda.
- Federal Public Drug Plans, with respect to the reimbursement of drug products for the Federal plan beneficiaries
- Science and Technology Strategy, advocating for the development of a Biopharma sector in support of more research & development in Canada.
Policies or Program, Regulation
- R&D requirements set forth through the Patent Medicines Pricing Review Board (PMPRB)
- Subsequent Entry Biologics (SEBs)/ Biosimilars: information regarding approval framework supported and protected by Regulations in harmonization with approaches taken by the European Union or the U.S. for instance.
Regulation
- Patented Medicine Prices Review Board (PMPRB) Regulations as related to reporting requirements and pricing guidelines.
- Patented Medicines (Notice of Compliance) Regulations as it relates to regulation of intellectual property for therapeutic products. Novartis is working with our industry associations (Innovative Medicines Canada and BIOTECanada) to provide a written response to Guideline consultation process and will also provide our own corporate submission.