Our Medicines
The Next Generation of High Quality
Cost-Saving Medication – Complex Generics
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