Health Canada implements ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric PopulationPublished on June 6, 2018
Author: Karen Zhou
Health Canada has announced the implementation of the ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (the “Guidance”). In implementing the Guidance, Health Canada endorses the principles and practices described in the addendum.
In response to the regulatory and scientific advances since the original guideline was published in 2000, ICH developed the addendum to provide clarification and current regulatory perspectives on topics in pediatric drug development. The following sections have been added to supplement the original guideline:
1. Ethical considerations
2. Common scientific approach
3. Age classification
4. Approaches to optimize pediatric drug development
5. Practicalities in the design and execution of pediatric clinical trials
6. Pediatric formulations
· A fundamental principle of pediatric drug development is that children should be enrolled in a clinical study only if it is necessary to achieve an important pediatric public health need.
· Consistent with the general principles of ethical considerations for parental consent/permission and child assent over the course of a clinical study, it may be necessary to reassess the assent of a child in recognition of the child’s evolving maturity and competency.
Common scientific approach
· Pediatric drug development programs should adopt a common scientific approach to address the regional differences in regulatory requirements, operational practicalities, standards of care, and cultural expectations.
· Selection of a pediatric population should also consider physiological development, maturity of organs, pathophysiology and natural history of the disease or condition, available treatment options and the pharmacology of the investigational product.
Approaches to optimize pediatric drug development
· Alternative approaches should be developed to address the evolving nature of regulations and difficulties of generating data across pediatric populations. One approach is to use existing knowledge in pediatric drug development through data analytics, including extrapolation, modelling, and simulation.
Practicalities in the design and execution of pediatric clinical trials
· Factors that influence the design and execution of pediatric clinical trials include feasibility, outcome assessments and long-term clinical effects.
· Pediatric formulations should also consider age-appropriate dosage forms, ease of preparations and instructions for use for caregivers, acceptability, choice and amount of excipients, use of alternative delivery systems and appropriate packaging.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media
Notice: (ICH) Guidance: E11(R1) Addendum (April 5, 2018)
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...