The International Council for Harmonisation: Positioning for the future with its recent reform and over 25 years of harmonisation work

Article type: Research Article

Authors: Lourenco, Celia^{a; d; *} | Orphanos, Nikolas^a | Parker, Catherine^{b; c; d}

Affiliations: [a] Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada | [b] Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada | [c] Health Canada representative at the ICH Assembly | [d] Health Canada representative at the ICH Management Committee

Correspondence: [*] Corresponding author: Celia Lourenco, 101 Tunney's Pasture Driveway, Room B227, Ottawa, K1A 0K9, ON, Canada. Tel.: +1 613 941 2588; Fax: +1 613 941 1183; E-mail:[email protected]

Abstract: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, also known as ``ICH'', is a key international harmonisation initiative founded by the drug regulatory authorities and industry associations from the European Union, Japan and the United States of America. The main objective of ICH is to promote public health globally through the development and implementation of harmonised guidelines and standards. With its recent reform, ICH became an Association under Swiss law, and set the stage to broaden its membership to regulatory authorities and international pharmaceutical industry associations beyond the three founding regions. Building on greater than 25 years of harmonisation work, ICH is now well-positioned to grow into a truly global venue for the development of guidelines and standards to facilitate the registration of human medicines across the world.

Keywords: Pharmaceutical, regulation, harmonisation, guidelines, standards

DOI: 10.3233/PPL-160434

Journal: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 79-89, 2016