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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight, compared...

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Orphan Drug Approval in Canada, 1999-2022: A Cross-sectional Study.

Joel Lexchin1,2

  • 1School of Health Policy and Management, York University, Toronto, ON, Canada.

International Journal of Health Policy and Management
|April 12, 2026
PubMed
Summary

Canada approves 70.9% of US Food and Drug Administration (FDA) orphan drugs, with a median 346-day delay. The therapeutic value of new orphan drugs has significantly decreased, impacting Canadian drug policy.

Keywords:
Drug ApprovalFood and Drug AdministrationHealth CanadaOrphan DrugsTherapeutic ClassTherapeutic Value

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Area of Science:

  • Pharmacoeconomics
  • Health Policy
  • Drug Approval Processes

Background:

  • Increasing number of orphan drugs in Canada.
  • Significant federal investment in funding orphan drugs.
  • Debate surrounding availability and approval timelines of orphan drugs in Canada compared to the FDA.

Purpose of the Study:

  • To objectively assess the percentage of US Food and Drug Administration (FDA)-approved orphan drugs also approved by Health Canada.
  • To determine the time lag between FDA and Health Canada approval for orphan drugs.
  • To evaluate the additional therapeutic value of newly approved orphan drugs.

Main Methods:

  • Analysis of FDA and Health Canada databases.
  • Inclusion of data from three health technology assessment agencies and one drug bulletin.
  • Comparison of orphan drug approvals and their therapeutic value from 1999 to 2022.

Main Results:

  • Health Canada approved 231 out of 326 (70.9%) FDA-approved orphan drugs between 1999 and 2022.
  • Median delay between FDA and Health Canada approval was 346 days.
  • Proportion of orphan drugs rated as major improvements decreased from 50% (2004-2008) to 13.6% (2019-2022).

Conclusions:

  • Canadian orphan drug policy and funding criteria require consideration of these findings.
  • Risk-sharing agreements with manufacturers are recommended when high-quality evidence of therapeutic value is lacking at approval.
  • Funding withdrawal should be considered if post-market trials fail to demonstrate convincing value; research plan quality should guide funding prioritization.