Food & Drug Regulatory
Torys’ practitioners are experienced in the relevant regulatory laws, guidelines and policies—both federal and provincial—and regularly advise on all of the regulatory issues affecting the research, testing, approval, post-approval compliance, pricing, advertising and correction/withdrawal/recall of drugs, food and beverage products, cosmetics, consumer products, nutritional products, and medical devices/diagnostics products in Canada.
Our team also assists clients with conducting compliance audits, privacy laws, recalls and withdrawals, non-compliant regulatory submissions, and obtaining regulatory approvals, including presubmission meetings with regulatory authorities (NHP applications, NDS, SNDS, IND, DIN and other license submissions).
Our cross-border expertise extends to advising clients on the differences in compliance in Canada and the United States, patent listings in Canada, U.S. websites and promotion and advertising of U.S.-labelled product for purchase by Canadians, compliance and cross-border issues in corrective actions, as well as privacy issues associated with collecting data from Canadians and exporting to servers located in the United States and advising on applicable consents and website terms and conditions.
Our expertise includes the following:
- determining how a product or service is classified and regulated
- if pre-approval of a product is required in Canada, assisting with pre-submission meetings, regulatory submissions, establishment license applications and registrations, ISO certifications, responses to comments of regulators, post-submission meetings, approvals and product launches
- providing strategic advice on best practices for maintaining a product’s market exclusivity
- corporate compliance codes, regulatory compliance audits, GMP compliance
- product packaging, labeling, advertising, promotions, contests, websites
- regulatory-related agreements including quality assurance and pharmacovigilance agreements and commercial agreements with a regulatory component
- pricing and market access of products
- the interface between regulatory submissions, patent listings and data protection
- Patented Medicines Prices Review Board (PMPRB) hearings and negotiations with PMPRB staff in Canada
- advertising complaints and disputes before PAAB, ASC and other organizations (brought by or against competitors)
- public and private formularies/payers and agreements with such formularies/payers
- privacy issues associated with collecting, using and sharing data, personal information and personal health information, including corrective action associated with disclosures
- planned and unplanned inspections by regulatory authorities (pre- and post-approval, and cross-border)
- compliance and cross-border issues in corrective actions, product corrections, recalls and withdrawals
- consumer, patient and physician support websites