Our Medicines
Bringing High Quality Cost-Saving Generic Prescription Medicines to Canadians
Generic drugs can be manufactured after the periods of exclusivity on the brand-name versions have ended. Generic and brand-name drugs have identical active ingredients, and generic drugs must meet Health Canada’s standards for bioequivalence.
The process of bringing a generic prescription medicine to Canadians is complex, requires sophisticated scientific and advanced manufacturing technologies, and can take several years and millions of dollars to complete.
Launching a new prescription medicine requires investments in R&D, product development, testing in clinical trial settings, and the application of innovative and advanced manufacturing processes for Health Canada reviews and approval.
Medicines
The Timeline to Bring New Generic Prescription Medicines to Canadians
01
Securing Active
Pharmaceutical Ingredients
(API’s) & Quality Control
• Active Pharmaceutical Ingredients
(APIs) are produced internally, or
sourced from international suppliers.
• API tested for quality and
consistency prior to formulation.
• Assess quality control and
manufacturing practices of supplier
01
Securing Active
Pharmaceutical Ingredients
(API’s) & Quality Control
• Active Pharmaceutical Ingredients (APIs) are produced internally, or sourced from international suppliers.
• API tested for quality and
consistency prior to formulation.
• Assess quality control and
manufacturing practices of supplier
Formula
Development
• Originator product is reverse engineered for composition of active and non-active ingredients.
• Various formulations of active and non-active ingredients.
• Develop quality control matrix for formulation integrated into manufacturing.
02
Formula
Development
• Originator product is reverse engineered for composition of active and non-active ingredients.
• Various formulations of active and non-active ingredients.
• Develop quality control matrix for formulation integrated into manufacturing.
03
Manufacturing and
Production Testing
• Analysis of manufacturing complexity and requirements.
• Equipment designed and/or purchased for dedicated production line.
• Quality control matrix developed, tested for full manufacturing.
03
Manufacturing and
Production Testing
• Analysis of manufacturing complexity and requirements.
• Equipment designed and/or purchased for dedicated production line.
• Quality control matrix developed, tested for full manufacturing.
Bioequivalence Studies
And Clinical Trials
• Bioequivalency studies undertaken to measure the rate and the extent of absorption of generic drug. Results compared to originator drug.
• Comparative study submitted to Health Canada.
04
Bioequivalence Studies
And Clinical Trials
• Bioequivalency studies undertaken to measure the rate and the extent of absorption of generic drug. Results compared to originator drug.
• Comparative study submitted to Health Canada.
05
Regulatory and
Legal Challenges
• Under Patented Medicines (Notice of Compliance) Regulations a generic manufacturer is required to serve Notice of Allegation on the brand name manufacturer, claiming generic drug will not infringe any relevant patents..
05
Regulatory and
Legal Challenges
• Under Patented Medicines (Notice of Compliance) Regulations a generic manufacturer is required to serve Notice of Allegation on the brand name manufacturer, claiming generic drug will not infringe any relevant patents.
• Brand-name manufacturer can apply for an order prohibiting Health Canada from approving generic drug.
Provincial / Territorial
Drug Plan Listings
• Once Health Canada has issued a Notice of Compliance (NOC) and approved the drug for sale, it can be sold anywhere in Canada.
• To be reimbursed under provincial drug programs and obtain significant sales volumes, the generic drug must be listed on provincial drug benefit plans and be “interchangeable” with originator.
06
Provincial / Territorial
Drug Plan Listings
• Once Health Canada has issued a Notice of Compliance (NOC) and approved the drug for sale, it can be sold anywhere in Canada.
• To be reimbursed under provincial drug programs and obtain significant sales volumes, the generic drug must be listed on provincial drug benefit plans and be “interchangeable” with originator.
07
Patient Journey
• Patient Support Programs
• Access and Education
07
Patient Journey
• Patient Support Programs
• Access and Education