Orphan drug regulations
Country : Canada

No orphan drug policy

i. Emergency drug release program/investigational new drugs (EDRP/IND) provides access to
unapproved drugs.

ii. SR and ED [scientific research (SR) and experimental develop ment (ED)] tax incentive program would
support R and D in the area of orphan drugs.

iii. Provision for reduction of fees for small market drugs under cost recovery.

iv. Process patents granted for biotechnology products

Country :US

Orphan drug act (January 4, 1983)

i. Designation granted based on prevalence of disease in the population of less than 200,000 people
(approximately 0.1%) or no reasonable expectation of profitability

ii. Protocol assistance to design research protocols

iii. Tax credits for clinical research

iv. Market exclusivity

v. Funding grants for clinical research to support development vi. Penalty for intentionally false
statement of orphan status

vii. Parallel track program and treatment INDs provide access to unapproved drugs

viii. Process patents granted for biotechnology products accelerated approvals

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