Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products

February 26, 2020

Our file number: 19-122718-811

Health Canada is pleased to announce the release of the draft guidance document Comparative Pharmacokinetic Studies for Orally Inhaled Products for stakeholder consultation.

The purpose of this document is to provide sponsors of new drug submissions and abbreviated new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations, with respect to comparative pharmacokinetic studies, with emphasis on in vivo comparative pharmacokinetic studies, used in support of the safety and efficacy of subsequent-entry orally inhaled drug products (OIP).

This guidance will apply to all comparative pharmacokinetic studies that provide pivotal evidence of the safety and efficacy of a subsequent-entry OIP, including orally inhaled pressurized metered dose inhalers, dry powder inhalers and nebulization products. These products may contain, for example, inhaled corticosteroids, long-acting beta2-adrenergic agonists, long-acting muscarinic antagonists, or combinations of these drugs. This guidance will also apply when a significant change is made to a reference product, such that a comparative clinical trial would previously have been required in support of the change. 

The development of this draft guidance document is the result of consultation with Health Canada’s Scientific Advisory Committee on Respiratory and Allergy Therapies, a survey of the scientific literature and other regulators’ approaches to the use of comparative pharmcokinetic and in vitro data to establish the safety and efficacy of subsequent-entry orally inhaled products.

Comments should be provided to Health Canada, preferably in electronic format using the attached template, within 90 days from the date of this notice. All comments will be considered in the finalization of the guidance.

Comments should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Fax: (613) 941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca

Comment template:

Draft Guidance Document: Comparative Pharmacokinetic Studies for Orally Inhaled Products

Published for External Consultation on February 26, 2020

Comments submitted by: <full name>, <company/association name (if applicable)>
Telephone number: <telephone number>
Address: <full mailing address>
Email: <email address>
Date: <date of comment submission>

Comment template

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