Table 1 Primary list of criteria

Use in reference countries

To assure approval from other trusted marketing authorization bodies

Equivalence with the reference product

To capture evidence on equivalence with originator product (bioequivalence, efficacy, safety)

Active pharmaceutical ingredient (API) manufacturing quality

To capture evidence on API manufacturer quality and standardization

Finished product manufacturing quality

To capture evidence on pharmaceutical product manufacturer quality and standardization

Pharmacovigilance services

To capture evidence on provision of proper pharmacovigilance services

Supply reliability

To capture reliability and stability of drug supply (to avoid shortages)

Previous use in local settings

To consider previous local insights and experience with the product

Macro-economic benefit

To capture wider economic benefits of selecting the medicine (e.g., tax, investment, employment, etc.)

Ease of use

To assure ease of use and convenience from the healthcare facility perspective

Expiry date

To incentivize products with high stability and further expiry ranges

Storage conditions

To incentivize products that do not require special storage conditions

Refund or replacement of expired products

To incentivize manufacturers who provide refunds or replacements of expired products

Production capacity and financial ability of the company

To ensure the manufacturer’s ability to supply the required quantities without shortages and on time