약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 3.

Table. 3.

Charging for investigational drugs

Country Charging/Fees
United States Charging for investigational drugs under an IND (CFR 21 §312.8)
• A sponsor must obtain prior written authorization from FDA to charge for an investigational drug
• FDA will withdraw authorization to charge if it determines that charging is interfering with the development of a drug for marketing approval or that the criteria for the authorization are no longer being met
• A sponsor may recover only the direct costsa of making its investigational drug available
• For expanded access to an investigational drug for treatment use, a sponsor may recover the costs of monitoring the expanded access IND or protocol, complying with IND reporting requirements, and other administrative costs directly associated with the expanded access IND
Australia • There is no cost associated with applications or notifications to TGA to access or supply unapproved therapeutic goods through the SAS
• The Commonwealth does not subsidise the cost of unapproved therapeutic goods through the Pharmaceutical Benefits Scheme (PBS)
• In some circumstances and at their own discretion, a sponsor may provide a therapeutic good to a patient on a compassionate basis (referred to as compassionate supply) at reduced or no cost
United Kingdom • Medicines must be provided free of charge by the manufacturer and billing is not possible
• There are administration and application feesb
Republic of Korea 「Regulation on Safety of Pharmaceuticals, etc.」 Article 29
• Free supply is the basic principle
• The provider of an investigational product may charge the patient to whom the investigational product is administered the cost of the corresponding investigational product at its cost of productionc
• Exceptional billing is possible (high-priced new drugs such as biopharmaceuticals)

aDirect costs include costs per unit to manufacture the drug or costs to acquire the drug from another manufacturing source, and direct costs to ship and handle the drug

bThe fee for the PIM designation is £3,624; The fee for assessment of the scientific opinion for new chemical or biological medicinal products is £25,643 and the renewal fee (if applicable) is £12,821; The fee for the assessment of the scientific opinion for new indications is £8,309 and the renewal fee (if applicable) is £4,154

cRefers to the costs directly incurred in the manufacture of investigational product used on individual patients excluding expenses for facilities and environmental management, etc. and research and development costs

Yakhak Hoeji 2021;65:441-52 https://doi.org/10.17480/psk.2021.65.6.441
© 2021 Yakhak Hoeji