Novartis Pharmaceuticals Canada Inc.
Registration:
3
of
38
(2010-01-04
to
2011-02-02)
Legislative Proposal, Bill or Resolution
- Bill C-6, Canada Consumer Product Safety Act with respect to creating a new system to regulate consumer products that pose, or might reasonably be expected to pose, a danger to human health and safety.
- Food and Drugs Act & Regulations as it relates to Drug Export restriction and cross border trade.
Legislative Proposal, Bill or Resolution, Regulation
- The upcoming Food and Drugs Act Modernization legislative provisions (and Regulations) as it relates to improving the efficiency of the drug approval system.
Policies or Program
- Common Drug Review as it relates to reimbursement recommendations for decision-making process and framework.
- 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
- Subsequent Entry Biologics (SEBs): seeking an 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.