00000nam 2200000zi 4500 9.863526 CaOODSP 20221107161312 m o d f cr ||||||||||| 181019t20182018onc #ob f000 0 eng d 9780660282299 CaOODSP eng rda CaOODSP n-cn--- H13-9/29-2018E-PDF Guidance document : data requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma. Data requirements for safety and effectiveness of subsequent entry inhaled corticosteroid products used for the treatment of asthma Data requirements for safety and effectiveness of subsequent entry ICS for asthma Ottawa, ON : Health Canada, 2018. ©2018 1 online resource (14 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from cover. "Date Adopted: 2018/10/16 ; Effective Date: 2018/11/01." Issued also in HTML format. Issued also in French under title: Ligne directrice : exigences relatives à l'innocuité et l'efficacité pour des corticostéroides inhalés de commercialisation subséquente utilisés dans le traitement de l'asthme. Includes bibliographical references. "This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP) in order to meet the safety and effectiveness requirements under C.08 of the Food and Drug Regulations [Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3)]. The data and standards outlined in this guidance are intended to be applied to a new ICS product being compared to a product for which clinical safety and effectiveness data exist. For clarity, these types of products will be referred to as “subsequent entry ICS products” in this document"--Introduction, page 5. gccst Health care products gccst Safety standards gccst Comparison Canada. Health Canada. Ligne directrice : (CaOODSP)9.863527 PDF 260 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-29-2018-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhaled-corticosteroid-profile/inhaled-corticosteroid-guidance.html Pub.: 180404