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Nos médicaments

La nouvelle génération de médicaments

de haute qualité et abordables : les génériques complexes

Un générique complexe est une nouvelle version abordable d’un produit de marque « spécialisé » utilisé pour traiter des maladies chroniques et complexes telles que l’asthme, l’hypertension et l’ostéoporose, entre autres. Les génériques complexes sont des produits contenant plusieurs ingrédients actifs, formulations ou voies d’administration, et chacun d’entre eux doit inclure des programmes de soutien aux patients continus. La création et la fabrication de génériques complexes nécessitent des niveaux d’expertise, de planification, de développement et de coût plus élevés que les génériques standard. 

 

Les sociétés membres de l’ACMG ont réalisé des investissements importants dans la R&D, la fabrication, les essais cliniques ainsi que dans les programmes et services visant à lancer ces nouveaux produits et à générer des économies potentielles de plusieurs centaines de millions de dollars. L’industrie prévoit qu’au cours des prochaines années, les génériques complexes représenteront la majorité des nouveaux produits génériques lancés au Canada. L’engagement à utiliser davantage la prochaine génération de médicaments de haute qualité et économiques contribuera de manière significative à la pérennité du système de santé et à la vitalité de l’industrie nationale.

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