Nos médicaments
Offrir aux canadiens des médicaments génériques économiques de haute qualité
Les médicaments génériques peuvent être fabriqués après la fin des périodes d’exclusivité des versions d’origine. Les médicaments génériques et les médicaments d’origine ont des ingrédients actifs identiques, et les médicaments génériques doivent répondre aux normes de bioéquivalence de Santé Canada.
Le processus de développement d’un médicament générique sur ordonnance au Canada est complexe, exige des technologies de fabrication scientifiques avancées, et peut prendre plusieurs années et des millions de dollars pour arriver à terme.
Le lancement d’un nouveau médicament sur ordonnance nécessite des investissements en recherche et développement, en développement de produits, en essais cliniques et en application de processus de fabrication innovants et avancés pour l’évaluation et l’approbation de Santé Canada.
Médicaments
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