Draft guidance document on comparative pharmacokinetic studies for orally inhaled products: Closed consultation

From Health Canada

Current status: Closed

This consultation ran from February 26, 2020, to May 26, 2020.

This guidance document provides 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. The information is related to comparative pharmacokinetic studies, with emphasis on in vivo comparative pharmacokinetic studies, used to support the safety and efficacy of subsequent-entry orally inhaled drug products (OIP).

Who was the focus of this consultation

We engaged with:

• members of the pharmaceutical industry
• health professionals

Goals of the consultation

The goal of this consultation was to receive feedback on the guidance document on comparative pharmacokinetic studies for orally inhaled products. This guidance document informs stakeholders on the submission requirements for orally inhaled products. It also provides more clarity, consistency, transparency and predictability for manufacturers in filing drug submissions.

Key questions for discussion

We sought comments or concerns from stakeholders regarding the guidance document on comparative pharmacokinetic studies for orally inhaled products.

Contact us

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 ON  K1A 0K9
Fax: (613) 941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca