Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT) – Announcement of Meeting

Ottawa, Ontario
November 2, 2018

The purpose of this Notice is to announce an upcoming meeting of Health Canada's Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).

The advice received from this meeting will be used to make decisions on drug submissions filing requirements and to develop guidelines to be used by industry.

Mandate of the SAC-RAT

Provide timely scientific, medical and clinical advice related to the regulation of respiratory and allergy therapies.

For more details, please refer to the Terms of Reference of the SAC-RAT.

Meeting format

Health Canada will make a presentation to the panel summarizing background information, to provide context for the questions posed.

Upon completion of the presentation and associated discussion, the panel will deliberate in a closed meeting before providing their final advice to Health Canada.

Agenda

Health Canada would like to discuss the scientific and regulatory requirements, particularly with respect to the use of pulmonary pharmacokinetic studies, for establishing bioequivalence (BE) of subsequent market entry (SME) orally inhaled products (OIPs) for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). The discussions will pertain to inhaled corticosteroids (ICS), long-acting beta2-adrenergic agonists (LABA), long-acting muscarinic antagonists (LAMA), and combinations thereof.

The detailed agenda will be posted at the same time as this meeting announcement.