01Generic alternatives
Standard or complex products that could add reliable choice where competition or regional availability is limited.
Established medicines
Improving access to established medicines
We assess generic and established medicines where a better product, another reliable source or a clearer route to supply could meet a defined healthcare need.
01
Opportunities
Where established medicines can add value
An established active ingredient can still require meaningful pharmaceutical development.
01
02Product improvements
New strengths, formulations, routes, combinations, packs or presentations that address a practical limitation in use.
03Supply continuity
Additional sources for medicines whose supply is concentrated, vulnerable or poorly matched to sustained local demand.
02
Assessment
What makes an opportunity credible
The need, product and supply route must work together.
Defined need
Who would benefit, and what limitation in access, use or supply would change?
Product feasibility
Can the formulation, analytical controls, materials and process meet the required quality and scale?
Regulation and rights
Are the evidence, dossier, registration route and product rights clear for the intended territories?
Market access
Is there durable demand and a practical pricing, reimbursement and distribution route?
Continuity and viability
Can the product be supplied consistently and supported across its lifecycle?
03
Development route
From need to reliable supply
- 01
Define the need
Specify the product, people, territory and access or supply problem.
- 02
Test feasibility
Review the evidence, product requirements, rights, regulatory route and economics.
- 03
Build the plan
Set the development, registration, manufacturing and supply responsibilities and milestones.
- 04
Develop and maintain
Complete the agreed work, prepare supply and review quality and continuity through the lifecycle.
Product opportunities
Have an established product, dossier or supply need worth assessing?